Upstream Issue Meaning Jobs in Usa
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Opportunity Snapshot:
- Compensation: $100.00/hour
- Location: Spring, TX
- Assignment Duration: 12 months +
- Work Schedule: Monday-Friday, 40 hours + (in-office)
- Benefits: Comprehensive with 401K, holidays and PTO
- Experience with Oil & Gas Industry a hard requirement!
Qualifications:
- Bachelor's degree preferred
- 3+ years experience in the Oil & Gas industry required. Experience with understanding Unconventional supply chains preferred
- Strong experience with Visio required
- Strong knowledge of Power BI, Excel, SQL
- Strong communication and presentation skills, process mapping and MS Office
Responsibilities:
- Solve organizational problems by analyzing business requirements, documenting processes and designing solutions
- Identify and organize fragmented or missing data across supply chain processes
- Develop dashboards, reports and KPIs to support decision-making and operational transparency
- Track and report statistics, implementation processes, risks and challenges
- Conduct issue investigations and perform data mining to identify root causes and improvement opportunities
- Conduct interviews with key project stakeholders and document and presents the results
- Recommend process improvements and alternative solutions
- Assist business users, project managers and leadership in optimizing the scope, benefits and risks of proposed projects
- Facilitate change management efforts associated with project
- May write and maintain user documentation
- Position will receive direction and support
- Minimal work direction needed, highly skilled and knowledgeable to the position
- Take care of complex scoping issues, perform project estimation, make recommendation for requirements approach, understand and manage principles of business strategies
The Bergaila Way:
The Bergaila Companies is a nationally recognized leader in providing staffing services to all sectors of the energy industry. We continually focus on partnering with talented professionals, engineering the perfect fit between our clients and employees. Choosing a career path with Bergaila grants you immediate access to nationally recognized organizations we partner with. Bergaila consistently attracts and retains its Employees with our dedicated internal service team, top tier benefits programs for contractors and their families, and commitment to place you in the desired career of your choice.
Client Overview:
Our Client is an American energy company operating principally in the U.S. and Canada, that specializes in the drilling and production of unconventional oil and natural gas assets. Our client has a reputation for efficient resource development, environmental stewardship and community involvement, with a drive to meet the growing challenges of the domestic natural gas industry.
Position Summary:
The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.
Key Responsibilities:
- Author, review and approve analytical method procedures/SOPs
- Author, review and approve analytical method transfer/qualification/validation protocols and reports
- Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
- Establish and manage reference standard and critical reagent programs
- Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
- Perform data verification and audits in order to ensure accuracy of data and analytical processes.
- Ensure compliance with company policies and SOPs as well as global health authority guidelines.
- Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
- Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
- Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.
Qualifications:
- Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
- Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
- Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.
Knowledge and skills (general and technical) preferred:
- Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.
Education level and/or relevant experience required:
- Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.
About Upstream Bio:
Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .
Compensation
Target Salary Range: $176,400 - $215,600
*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
*** Sign on Bonus ***
About Means Engineering, Inc.
Means Engineering, Inc., headquartered in Carlsbad, CA, delivers innovative solutions across the medical, industrial, semiconductor, and military sectors. We combine deep expertise in product development with a relentless commitment to design, function, and quality.
Our team is guided by our core values — Passion, Integrity, Innovation, Quality, and Ethics — ensuring every project meets the highest standards. Join us and be part of a company that values craftsmanship, collaboration, and excellence.
Key Responsibilities:
- Perform advanced-level setup and operation of milling, turning, and grinding machines.
- Troubleshoot and resolve machining issues quickly and effectively.
- Read and interpret blueprints, technical drawings, and job specifications.
- Execute high-precision benchwork and layout activities.
- Edit CNC setup sheets; suggest and implement programming or process improvements.
- Inspect parts to ensure conformance to quality standards and specifications.
- Accurately document work in the ERP system, including job status, time tracking, and nonconformance reports.
- Collaborate with Process Engineering on new product introduction (NPI) and continuous improvement projects.
- Maintain a clean, organized, and safe work environment; follow all company policies and safety
Qualifications:
- Minimum of 7 years of related machining experience.
- Strong English communication skills – able to understand verbal and written instructions, collaborate with team members, and actively participate in meetings and training.
- Math proficiency in algebra, geometry, and trigonometry.
- Exceptional measurement skills with the ability to work within tight tolerances.
- Expertise in reading and interpreting technical drawings, specifications, and quality standards.
- Ability to document quality control requirements clearly and accurately.
- Solid understanding of tooling, equipment safety, and machining best practices.
- A proactive mindset for addressing non-conforming operations and producing accurate, high-quality parts within deadlines.
- Ability to work both independently and collaboratively, with experience mentoring junior team members
Duration: 06 months - 3 days onsite per week
Location: Chicago, IL or Tempe, AZ
Project Overview:
These contractor resources will support a broad range of Workday integration initiatives across HR Technology, Finance, Procurement, and various business partners. Their efforts will span designing, enhancing, and maintaining integrations with multiple third party vendors, enabling new capabilities, optimizing existing data flows, and ensuring end to end data quality across upstream and downstream systems. They will contribute to solution design, field mapping, testing, troubleshooting, and deployment of Workday integration enhancements that improve operational efficiency, support evolving business requirements, and strengthen the overall Workday ecosystem.
Experience Level: 3 - Senior
Minimum qualifications:
- Bachelor's Degree in computer science or engineering
- 5+ years of work experience in in Workday, Integrations and API integration
Qualifications (must haves):
- Hands on work experience with Workday
- Experience with Workday Projects (preferably implementation experience)
- Able to write XSLT scripting both XSLT2.0/XSLT 3.0
- Hands on experience on Workday Studio
- Hands on experience in API integration either SOAP or Rest
- Hands on experience on PECI/WECI/PICOF and Core Connectors
- Understanding of Payroll data and Experience on US payroll and Global Payroll
- Ability to resolve issues/troubleshoot application in a high-pressure & time critical environment
- Experience using ITSM Service now tool
- Self-motivated to initiate actions and be responsible for consequent decisions.
- Good programming and debugging skills.
- Strong analytical, design thinking and problem solving skills.
- Strong written/verbal communications skills.
- Good team player and interpersonal skills.
Nice to Have:
- Hands on experience on ADO ( Azure Devops) .
- Exposure to Agile practices ( Scrum /Kanban) .
- Understanding of ITIL Process guidelines, with specific focus on Service Operations and Incident Management.
- Functional Knowledge of HR in finance business.
- ServiceNow Development
Tasks & Responsibilities:
- Resolve incidents/failures and ensure closure within the SLAs
- Development of New Integrations within HR Workstream
- Collaborate with business partners on new and ongoing Workday Projects
- Efficiently Debug issues in case of Production Failure
- Participate in root cause analysis and provide solution/work around for HR cases
- Debug issues , incidents and provide solutions for the same through hands on development
- Proactively identify & implement opportunities to increase efficiency through automation & process efficiencies
- Participate in engineering efforts for ETL solutions i.e. system design , build, deployment, best practices and testing
- Create well documented change requests and follow up for approvals
- Communicate with global stakeholders, other IT teams, and business areas
- Provide Level 3 Support during the time of Production Failures
- Should be flexible for upskilling in different skill sets
- Work with upstream and downstream application teams for any risks or potential issues
This role is responsible for troubleshooting mechanical breakdowns, maintaining production equipment, and minimizing downtime to ensure efficient operations and product quality.
The ideal candidate will have a strong mechanical background, experience working with production equipment or machinery, and the ability to quickly diagnose and repair machine issues.
Candidates with experience in high-speed manufacturing, automotive mechanics, HVAC, machining, or similar mechanical fields are highly encouraged to apply.
In-person interviews will be conducted.
Required Pre-Screening Questions Candidates must answer the following questions during the screening process: How do you go about troubleshooting a mechanical breakdown? What steps would you take to replace a gear box? What process would you use to determine the root cause of a machine malfunction? Equipment Maintenance Technician Compensation The pay for this position is $23.50/hr Benefits are available to full-time employees after 90 days of employment A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates Equipment Maintenance Technician Highlights This position is a contract assignment with potential to hire on permanently based upon attendance, performance, and business needs The required availability for this position is 3rd Shift – Sunday through Thursday, 12:00 AM – 8:00 AM Equipment Maintenance Technician Responsibilities Respond to and repair machine breakdowns and production equipment issues Troubleshoot speed, operation, and waste issues affecting production efficiency Set up, operate, optimize, changeover, troubleshoot, and maintain assigned equipment Maintain production standards while ensuring product quality and minimal downtime Operate equipment within specified quality and quantity limits Set up and debug machinery according to specifications and plant procedures Adjust, troubleshoot, clean, and repair equipment as needed Perform preventative maintenance (PM) to ensure smooth equipment operation Read machine blueprints and follow troubleshooting procedures Start up machines and verify proper function of equipment and control panels Maintain equipment maintenance logs and downtime records Document maintenance issues and operational data clearly and accurately Monitor component inventory levels and coordinate with material handlers when supplies are low Monitor in-process quality and perform required quality control checks Address jams or operational issues quickly and restart equipment safely Support upstream and downstream production operations Maintain a clean and organized production environment Follow all safety, environmental, and quality system requirements Ensure all machine guards and safety components are functioning properly Work effectively in a team-oriented, continuous improvement environment Equipment Maintenance Technician Requirements Top Required Skills Candidates must meet these requirements to be considered: Strong mechanical troubleshooting experience Experience using feeler gauges and other precision tools to measure tolerances, torque, and clearances Familiarity with mechanical components including: Cams and cam-followers Rod-ends and bushings Chain drives and conveyors Gear boxes Vacuum systems Pneumatic systems Ball valves Ability to lift and carry up to 50 lbs and push/pull up to 100 lbs Hands-on mechanical experience with machinery or equipment Preferred Background High-speed manufacturing environments Automotive or boat engine repair HVAC systems Machining or mechanical fabrication Experience with low-voltage electronics and sensors If you think this Equipment Maintenance Technician position is a good fit for you, please reach out to me—feel free to call, e-mail, or apply to this posting!
This role provides direct floor leadership to ensure compliant, efficient execution of production activities from line readiness through batch completion.
The Supervisor maintains an active presence on the floor to monitor aseptic behaviors, ensure SOPs/GDP adherence, and address non-compliant actions in real time.
Responsibilities include verifying in-process controls, ensuring accurate and timely documentation, overseeing changeovers and cleaning activities, and collaborating with Quality/Engineering to resolve issues, drive deviations investigations and CAPAs, and maintain audit ready operations.
The position is accountable for delivering safety, quality, OEE, and schedule adherence.
Job Description Shift/Hours: Mon-Friday 1st: 6:00am-2:30pm 2nd: 2:00pm-10:30pm 3rd: 10:00pm-6:30am Responsibilities: Lead end-to-end execution of the assigned ISO-classified cleanroom production line by verifying readiness (people, materials, documents, equipment), authorizing startup, supervising line operations, and ensuring accurate and timely batch documentation.
Serve as the line’s compliance leader, enforcing cleanroom discipline (gowning, behavior, material and personnel flow) and GDP practices.
Exercise authority to stop the line, escalate issues per procedure when controls are at risk, and correct any noncompliant behaviors in real time.
Perform and document all pre-run requirements, including line clearance procedures, environmental checks, tooling and parameter verification, material/label reconciliation, and verifying documentation is current, approved, and applicable to the process.
Maintain active presence on the floor to observe and ensure proper aseptic behaviors; provide timely coaching and corrective action; and stop work immediately when procedural drift is observed.
Ensure timely and accurate completion of production records, performing proactive page reviews and coordinating with QA to achieve accurate and timely closure of records.
Perform periodic in-process checks (functional and visual inspections) per MBR; quarantine nonconforming product promptly; and support on the floor triage and root cause assessment.
Coordinate structured changeovers and cleaning, including oversight of in-between batch cleaning activities.
Verify documentation quality and manage materials/logistics to maintain unidirectional flow and proper segregation.
Initiate deviations with objective evidence, perform impact assessments, support investigations/root cause analysis, and drive immediate corrective actions.
Escalate promptly in accordance with QCU authority.
Direct daily work and coach operator performance, qualifying employees to standard work, reinforcing retraining needs, and partnering with Training to ensure records remain current.
Champion safety and operational excellence by conducting Gembas, driving 6S and visual management standards, and leading Kaizen activities to reduce waste and improve OEE.
Act as primary contact for Quality, Maintenance, Engineering, and Supply Chain, ensuring structured shift handoffs and timely communication when issues arise.
Required Experience: High school diploma or equivalent.
3 years of aseptic manufacturing experience in GMP and ISO-cleanroom environments.
2 years of previous leadership experience working in an FDA-regulated environment.
Strong working knowledge of GMP regulations, aseptic techniques, and biopharmaceutical manufacturing processes, with the ability to execute work in compliance with SOPs, batch records, and technical documentation.
Demonstrated attention to detail with the ability to accurately complete GMP documentation and support investigations and escalate issues.
Effective communication and interpersonal skills, including the ability to guide and collaborate with others.
Must be able to maintain active and constant presence inside ISO-cleanrooms.
Fluently speak, read and write English.
Flexibility to work a modified schedule.
Preferred Qualifications: Bachelor's degree in STEM field.
5 years of hands-on experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing.
Effective problem solving/root cause analysis skills.
At least 1 year of experience managing people, including hiring, developing, motivating and directing people as they work.
Previous supervisory experience working in a FDA-regulated environment.
Advanced knowledge of upstream and/or downstream bioprocessing operations Experience supporting audits, inspections, and regulatory interactions Familiarity with continuous improvement methodologies and operational excellence initiatives Strong problem-solving skills with the ability to work cross-functionally Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $73,000.00
- $110,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
This role is bonus and/or incentive eligible.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Location: Biologics Pilot Lab - Foster City, CA
Duration: 12 months
Schedule: Onsite (Occasional weekend hours will be required)
Description:
About the Role
Join our Biologics Pilot Lab and contribute directly to the development, scaleup, and pilot-scale production of early and late-stage biologic programs. In this role, you will execute downstream purification operations, support upstream activities as needed, and help advance programs that are central to client biologics pipeline. This position is ideal for candidates who are hands-on in the lab, collaborative, and excited to work on fast moving development efforts.
About the Team
- You will join a team of seven scientists responsible for producing pilot-scale biological products that support biologics programs, trouble shooting and improving processes. The team implements new technologies to enhance operational capability, capacity, and efficiency across the site.
Key Responsibilities
- Technical & Operational
- Plan and execute downstream purification and scale-up activities including filtration, chromatography, and buffer preparation.
- Support upstream operations as needed to ensure seamless end-to-end process execution.
- Monitor, analyze, and interpret process and performance data; prepare clear summaries of findings as appropriate.
- Maintain laboratory readiness, including equipment maintenance, analytical instrument upkeep, consumable inventory management, and general lab support.
- Communication & Collaboration
- Present data, results, and conclusions in group meetings and cross functional discussions.
- Communicate technical information clearly and effectively to colleagues at varying levels.
- Work with a team-oriented, collaborative, and solutions-focused mindset.
- Maintain a strong safety focus in all laboratories and pilot operations.
Required Qualifications
- Hands-on experience with downstream purification operations, including centrifugation, chromatography, TFF, and depth filtration.
- Proficiency with AKTA systems and UNICORN programming.
- Practical experience in chromatography column operations, including resin packing and unpacking at various scales (e.g. 4.4 to 30 cm internal diameter columns).
- Strong verbal communication, technical writing, and documentation skills.
- Ability to work effectively in cross functional teams and in a dynamic environment.
- Self-motivated, organized, and comfortable with scientific problem solving.---
Preferred Qualifications
- Experience in pilot plant operations for biologics in a single-use facility.
- Familiarity with Process Development and/or current Good Manufacturing Practices (cGMP), technology transfer, plant operations, and bioprocess scaleup principles.
Education
- AA/AS degree with 2+ years of relevant industry experience (purification techniques), or
- BS/BE in Chemical/Biochemical Engineering, Biochemistry, Biology, or related discipline with 1+ year of relevant experience.
Work Requirements
This is a 100% onsite role in Foster City, CA.
Occasional weekend work required to support pilot-scale biologics operations.
Reason for Opening: Increased business needs and workload when FTEs are not available to meet timelines.
Interview Process
- Initial Zoom screening, followed by 1:1 interview with the hiring manager and 1-2 team members.
Onsite Offsite
- Onsite
Location: On-site in Upstate NY (Relocation from Canada welcome!)
Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.
This is an outstanding opportunity to join our growing team!
Full-Time | Onsite
About the Role:
We are seeking a detail-oriented and technically proficient Process Engineer who will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.
Responsibilities
- Work with Upstream equipment
- Fermentation
- Process optimization
- Process scale-up or scale-down studies
- Commissioning and Qualification
- Protocol generation and execution
- Data analysis
- Report writing
- Author SOPs
- Great communication skills (presenting, and writing)
- Protein expression/purification
- GxP (GDP, GLP, or GMP a major asset)
Minimum Requirements
- Bachelor’s or master’s degree in Biochemistry, Biology, Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline.
- Required: 3+ years of experience in the biotech-pharmaceutical academic or industrial environment.
- Bioprocess experience preferred
- Fill finish experience preferred
- Basic knowledge of upstream/downstream drug substance manufacturing.
- Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
- Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
- Demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment.
- Basic knowledge of the Commissioning and Qualification.
- Travel within USA as needed for the projects.
Perks & Benefits:
- Competitive salary
- Full health, dental, vision, and retirement benefits
- Tuition reimbursement, PTO, and more
Wholesale Operations Coordinator
Location: Ogden, UT (On-site)
Demand Planning Team | Reports to Demand Execution Lead
Compensation: $60,000 – $70,000 annually, based on experience
Position Summary
The Wholesale Operations Coordinator is the execution backbone of our wholesale planning
function. Where the Wholesale Planner works with retail buyers on assortment strategy and
demand forecasting, this role ensures that what gets planned actually gets delivered — on time,
accurately communicated, and with zero surprises.
This person owns the PO data layer for all wholesale accounts: managing purchase order
accuracy, aligning ship and cancel dates to inbound schedules and warehouse capacity, and
maintaining the operational rhythm that keeps wholesale fulfillment running smoothly. They are
also the primary point of contact for retail buyers on order status, communicating weekly
through structured order memos that provide clear visibility and proactive substitution guidance
when inventory constraints arise.
This role works in close coordination with the Wholesale Planner and reports to the Demand
Execution Lead, who oversees fulfillment operations for the team.
Key Responsibilities
1. Purchase Order Management
• Own the accuracy and maintenance of all wholesale PO data — including quantities,
ship dates, cancel dates, and item-level details — across all key accounts
• Monitor open PO status daily, flagging date conflicts, quantity discrepancies, or data
integrity issues before they become fulfillment problems
• Coordinate PO date adjustments in alignment with inbound shipment schedules and
warehouse receiving capacity, working closely with the Demand Execution Lead to
sequence orders appropriately
• Maintain clean and current PO records in the ERP system, ensuring data is reliable for
planning, finance, and operations teams downstream
• Partner with the Wholesale Planner to ensure order commitments reflect current
inventory availability and demand plan outputs
2. Inbound & Warehouse Coordination
• Track inbound shipments relevant to wholesale account fulfillment, maintaining visibility
into expected receipt dates and flagging delays that could impact ship windows
• Align wholesale ship dates to warehouse receiving and pick-pack schedules,
communicating proactively with the Demand Execution Lead when capacity conflicts
arise
• Flag hot inbounds — shipments that are critical to meeting imminent ship dates — and
coordinate with operations to prioritize receiving and processing accordingly
• Maintain a forward-looking view of what needs to arrive, when, and in what quantity to
support the wholesale order book without disrupting other channel operations
3. Weekly Buyer Order Memos
• Produce and distribute weekly order memos to retail buyers at all key wholesale
accounts, providing a clear and consistent update on order status, expected ship dates,
and any changes since the prior communication
• Proactively identify inventory constraints that affect open orders and develop substitution
recommendations in partnership with the Wholesale Planner — communicating these to
buyers clearly and in advance of ship dates
• Maintain a professional, reliable communication cadence with buyers that builds trust
and reduces inbound inquiries by getting ahead of questions before they arise
• Document buyer responses, acceptances, and substitution decisions, keeping the
internal team informed and the PO record updated accordingly
4. Data Integrity & Operational Reporting
• Serve as the first line of defense for wholesale order data quality — catching errors,
mismatches, and stale records before they surface as fulfillment issues or buyer
disputes
• Support the Wholesale Planner and Demand Execution Lead with regular reporting on
open order status, fill rate, and on-time ship performance by account
• Maintain item-level data hygiene for wholesale accounts including UPCs, pack
configurations, and account-specific requirements that affect order processing
• Flag patterns in order discrepancies, late shipments, or substitution frequency that signal
upstream planning or supply issues worth escalating
Qualifications
Required
• 2+ years in a supply chain, operations coordination, wholesale operations, or order
management role — ideally in a consumer goods or distribution environment
• Strong attention to detail and data accuracy; comfortable managing high volumes of
order-level information without losing precision
• Proficiency in Excel and/or Google Sheets and the ability to work efficiently with
structured data exports from ERP systems.
• Clear and professional written communicator — this role writes buyer-facing memos
weekly and needs to translate operational complexity into clean, readable updates
• Organized and proactive; able to manage multiple open order books simultaneously and
flag issues before they escalate
Preferred
• Experience with ERP systems (NetSuite or comparable) for PO management and order
data extraction
• Prior exposure to wholesale order management, retail routing guides, or account-specific
compliance requirements
• Familiarity with warehouse operations or inbound logistics coordination
• Experience working directly with retail buyers or customer service teams in a vendor or
supplier context
How This Role Fits the Team
The Wholesale Operations Coordinator works as the operational counterpart to the Wholesale
Planner. While the Planner owns the forward-looking view — assortment strategy, demand
forecasting, and account productivity — the Coordinator owns the execution layer: ensuring that
orders are accurate, dates are feasible, inbounds are tracked, and buyers are always informed.
Reporting to the Demand Execution Lead, this role is embedded in the day-to-day rhythm of
wholesale fulfillment and serves as the connective tissue between planning outputs, warehouse
operations, and the retail buyer relationship on order status matters.
Job Summary
The HR Operations Specialist is the first point of contact for employee and manager HR requests through QXO’s HR Service Center. This role delivers Tier 1 case based support across the employee lifecycle by resolving standard inquiries, completing defined HR transactions, and guiding leaders and employees to the right processes, tools, and policies. The Specialist documents work in the case management platform, meets service level and quality standards, and escalates sensitive, complex, or high risk issues to Tier 2, COEs, HRBPs, Employee Relations, Payroll, or Legal based on defined decision trees.
This role is critical to reducing back channel HR requests, improving consistency, and enabling self service by contributing to knowledge articles, templates, and digital workflows.
Key Responsibilities
Tier 1 Intake, Case Management, and Customer Support
- Serve as the primary Tier 1 contact for HR support through the HR case management system and approved channels (portal, phone, email, and messaging as applicable)
- Resolve standard requests related to HR policies, benefits navigation, leave intake and routing, pay, timekeeping, and employee data
- Apply approved scripts, workflows, and decision trees to ensure consistent guidance and case outcomes
- Document cases with complete notes, disposition codes, and audit ready attachments, ensuring accurate categorization for reporting and trend analysis
- Escalate cases that are sensitive, complex, or high risk using defined criteria and warm handoffs to the correct partner group (HRBP, Employee Relations, Payroll, Leave, Total Rewards, Legal)
HR Transactions and Data Quality
- Execute defined employee lifecycle transactions using standard operating procedures, including job changes, transfers, promotions, data changes, leaves, and separations, including coordinating required approvals and documentation
- Enter, validate, and audit employee data in the HRIS to ensure accuracy, completeness, and compliance
- Support employment verifications and personnel record requests in accordance with company policy and applicable requirements
- Maintain transaction quality through checklists and controls, escalating recurring errors or upstream process gaps
Time, Pay, and Leave Support
- Provide Tier 1 support for timekeeping questions and exceptions, including educating employees and managers on correct punches, transfers, and schedules, and partnering with Payroll and Time teams to resolve issues
- Support leave intake and routing for FMLA, ADA, and disability related processes, directing employees to the appropriate leave administrator or internal owner while maintaining privacy and documentation standards
- Explain benefit plan navigation, enrollment steps, and life event changes, directing employees to approved resources and vendor partners as needed
- Identify patterns in pay, time, or leave issues, and escalate systemic defects to functional owners with clear examples and impact
Policy, Risk, and Compliance Triage
- Communicate and reinforce HR policies consistently using approved language, and escalate when interpretation or exceptions are required
- Recognize potential compliance or employee relations risks and escalate promptly following defined thresholds
- Maintain confidentiality and handle employee data consistent with company standards and regulatory expectations
Knowledge, Digital Support, and Continuous Improvement
- Contribute to and maintain knowledge articles, templates, and standard responses to reduce repeat contacts and improve self service
- Tag cases accurately and surface trends, contact drivers, and opportunities for automation, workflow improvements, and policy clarification
- Participate in quality reviews and coaching to improve first contact resolution, cycle time, and customer experience
- Support the evolution of digital Tier 0, including testing knowledge content, validating intent categories, and identifying candidates for automation
Success Measures
- Service level attainment (response time, resolution time) and backlog management
- First contact resolution rate and appropriate escalation quality
- Case documentation quality and audit readiness
- Data accuracy and transaction quality
- Knowledge contribution volume and effectiveness, reduction in repeat contact drivers
- Customer experience results and professionalism
Qualifications
- 2+ years in HR operations, shared services, HR administration, payroll, timekeeping, or benefits support in a high volume environment
- Experience working in a case management platform and HRIS, strong documentation discipline
- Working knowledge of HR policies and common employee lifecycle processes
- Comfort operating with decision trees, scripts, service catalogs, and escalation criteria
- Strong customer service, judgment, and confidentiality
- Bilingual English and Spanish or French Canadian is a plus
Nice to Have
- UKG experience, especially timekeeping or scheduling
- Experience supporting a frontline, multi state workforce and managing high volume seasonal demand
- Experience contributing to knowledge bases or self service portals
QXO is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
This role requires strong mechanical troubleshooting skills and experience working with industrial equipment and mechanical components.
Candidates with backgrounds in automotive mechanics, HVAC, machinist work, boat engines, or high-speed manufacturing environments are encouraged to apply.
The ideal candidate is team-oriented, safety-focused, and committed to continuous improvement .
Key Responsibilities Set up, operate, optimize, troubleshoot, and maintain production equipment.
Respond to machine breakdowns and perform mechanical troubleshooting.
Repair equipment issues affecting speed, waste, or product quality.
Perform preventative maintenance according to plant PM programs.
Maintain accurate production, maintenance, and downtime logs.
Assist maintenance teams with major equipment repairs.
Monitor in-process product quality and perform required QC checks.
Ensure machines operate within quality and production standards.
Maintain clean and organized production areas.
Support upstream and downstream production processes.
Follow all safety, environmental, and quality system requirements.
Required Skills (Mandatory) Candidates must have all of the following: Strong mechanical troubleshooting experience Knowledge of feeler gauges and other precision tools used to measure tolerances, torque, and clearances Familiarity with mechanical components including: Cams and cam followers Rod ends and bushings Chain drives and conveyors Gearboxes Vacuum systems Pneumatic systems Ball valves Basic troubleshooting of these systems Ability to lift up to 50 lbs and push/pull up to 100 lbs Hands-on mechanical background Preferred Experience High-speed manufacturing equipment Automotive or diesel mechanics Boat or engine repair HVAC systems Low-voltage electronics and sensors Machinist experience Industrial production equipment troubleshooting Essential Functions Operate equipment within specified quality and quantity limits.
Set up and debug equipment according to specifications and procedures.
Adjust, troubleshoot, clean, and repair equipment as necessary.
Maintain equipment logs documenting downtime and maintenance issues.
Assist maintenance technicians with larger repairs when needed.
Start up equipment and ensure machines and control panels operate correctly.
Monitor component inventories and notify material handlers when supplies are low.
Clear jams and restart machine cycles safely.
Perform required process challenges and quality checks.
Maintain accurate production and downtime records.
Physical Requirements Lift and carry up to 50 pounds Push and pull up to 100 pounds Ability to work in a manufacturing environment and stand for extended periods Vision Requirement An eye exam will be required contingent upon hire.
This role requires: 20/30 vision with or without corrective lenses, and/or Successful completion of a color vision exam Education High School Diploma or GED required Pre-Screening Questions All applicants must answer the following: How do you go about troubleshooting a mechanical breakdown? What steps would you take to replace a gear box? What process would you use to determine the root cause of a machine malfunction?
This role serves as a technical and operational resource on the production floor, supporting production flow, compliance, and continuous improvement without formal supervisory authority.
Job Description AVAILABLE SHIFTS: 1st Shift: Mon-Fri 6am-2:30pm 2nd Shift: Mon-Fri 2pm-10:30pm 3rd Shift: Mon-Fri 10pm-6:30am MAJOR RESPONSIBILITIES Acts as a technical and workflow lead by coordinating daily manufacturing tasks, prioritizing activities, and supporting efficient production flow without formal people management responsibility.
Provides on-the-job guidance, mentoring, and training to manufacturing technicians and lower-level operators to ensure adherence to procedures, safety standards, and GMP requirements.
Performs advanced, hands-on biopharmaceutical manufacturing activities, including media and buffer preparation, aseptic processing, equipment cleaning and sterilization, and any responsibilities to support production and schedule adherence.
Sets up, operates, monitors, and adjusts bioprocessing equipment such as autoclaves, washer-sterilizers, filtration systems, fermenters, and fill-finish equipment.
Prepares, cleans, assembles, and stages tanks, glassware, components, and systems for batch manufacturing operations in accordance with approved procedures.
Monitors critical process parameters, production data, and outputs to ensure compliance with batch records, specifications, and quality standards.
Identifies, documents, and escalates deviations, abnormal events, and process issues in accordance with quality systems and regulatory expectations.
Maintains accurate and complete batch documentation, equipment logs, inventory records, and other GMP compliance documentation.
Follows and reinforces standard operating procedures (SOPs), manufacturing instructions, and all applicable safety, quality, and regulatory guidelines.
Collaborates with engineering, quality, and maintenance teams on troubleshooting, investigations, testing, and process optimization activities.
Supports continuous improvement initiatives by providing technical input, identifying opportunities for efficiency or quality improvements, and assisting with implementation of approved changes.
MINIMUM JOB REQUIREMENTS Education High school diploma or GED required Work Experience 2-3 years of manufacturing experience.
Experience in aseptic manufacturing experience in GMP and ISO-cleanroom environments.
Knowledge / Skills / Abilities Proven ability to operate, monitor, troubleshoot, and maintain biopharmaceutical manufacturing equipment.
Demonstrated attention to detail with the ability to accurately complete GMP documentation and support investigations and escalate issues.
Effective communication and interpersonal skills, including the ability to guide and collaborate with others.
Comfortable working in cleanroom and controlled environments while adhering to gowning, safety, and quality requirements.
Flexibility to work mandatory overtime based on business needs.
Ability to speak, read, and write English with proficiency PREFERRED JOB REQUIREMENTS Education Bachelor's degree in STEM field Work Experience 2 years of hands-on experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing.
Demonstrated experience performing advanced manufacturing operations such as aseptic processing, media/buffer preparation, and equipment operation Knowledge / Skills / Abilities Advanced knowledge of upstream and/or downstream bioprocessing operations Experience supporting audits, inspections, and regulatory interactions Familiarity with continuous improvement methodologies and operational excellence initiatives Strong problem-solving skills with the ability to work cross-functionally Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $28.75
- $41.75 Hourly The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Description
Ready for more than just a job? Build a career with purpose. At Lactalis in the USA, we're committed to providing meaningful opportunities for our people to learn, grow, and thrive-whether you're just starting your journey with us or looking to take the next step in your career. From day one, we offer the tools and support to help you succeed.
As the world leader in dairy, Lactalis is a family-owned company with over 85,000 pragmatic and ambitious professionals across the globe. Each day, we're proud to produce award-winning dairy products that bring people together.
In the US, we proudly offer an unrivaled house of beloved brands, including Galbani Italian cheeses and ricotta, President specialty cheeses and butters, Kraft natural and grated cheeses, Breakstone's cottage cheese, Cracker Barrel, Black Diamond cheddar, and Parmalat milk. Our yogurt portfolio includes siggi's, Stonyfield Organic, Brown Cow, Oui, Yoplait, Go-Gurt, :ratio, Green Mountain Creamery, and Mountain High, along with a growing family of ethnic favorites like Karoun, Gopi, and Arz.
At Lactalis, we live by our core values-Ambition, Engagement, and Simplicity. We foster a workplace where innovation thrives, diverse perspectives are celebrated, and everyone's unique background and ideas are valued.
Even if you don't meet every qualification, we encourage you to apply. We want to hear about your PASSION, your STORY, and how your EXPERTISE can help us shape the future of dairy.
From your PASSION to ours
Lactalis USA, part of the Lactalis family of companies, is currently hiring a Sr. Process Project Manager based in Casa Grande, Arizona. As a Senior Yogurt Process Project Manager, the role will carry out responsibilities such as but not limited to leading and executing strategic capital investment and process improvement projects that enhance the design, performance, and reliability of our yogurt manufacturing operations. The role includes overseeing projects from concept through full implementation, ensuring alignment with corporate standards, plant operational needs, and product quality expectations. Responsibilities include driving process design, managing cross-functional project teams, supporting production and quality operations, and ensuring successful commissioning of new or upgraded yogurt processing systems. Additionally, the Senior Yogurt Process Project Manager will collaborate with other Lactalis USA Corporate team members, the Lactalis Group Corporate Engineering & Equipment Department, R&D, Quality, Finance, and Plant Engineering and Operations teams to align duties with the company's goals and values.
- Define project objectives, deliverables, and performance criteria to support strategic business goals within yogurt manufacturing and processing.
- Conduct site assessments and feasibility studies to evaluate technical constraints, operational impacts, and cost-benefit considerations.
- Partner with Key Stakeholders at Corporate and Plant level - including Production, Quality, Planning, R&D, Finance, Safety, Maintenance, and Engineering - to obtain buy-ins and to ensure that project designs meet business, operational, and regulatory expectations.
- Develop complete project packages including process flow diagrams, P&IDs, equipment layouts, scopes of work, cost estimates, timelines, ROI, and risk assessments required for capital project justification and submittal.
- Identify, evaluate, and prequalify suppliers, engineering firms, and equipment vendors aligned with corporate standards and yogurt processing technology requirements.
- Lead vendor negotiations to secure competitive quotations for capital assets, installation services, and engineering support.
- Prepare comparative analyses and recommendations for purchasing decisions and capital investment approvals.
- Lead end-to-end project management for yogurt process initiatives, from conceptual design through commissioning, ramp up, project closure, and handover.
- Maintain and distribute comprehensive Project Schedules, identify critical paths, implement mitigation initiatives, and propose acceleration plans to ensure all projects are completed in accordance with the timelines in the Savings Plans and ROI calculations.
- Coordinate and facilitate project review meetings, develop and distribute meeting minutes, and escalate issues or risks to key stakeholders as required.
- Attend Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and commissioning activities to ensure equipment performance aligns with specifications and project objectives.
- Oversee installation, startup, and optimization of yogurt processing systems, resolving technical issues and ensuring seamless integration with existing operations.
- Ensure all projects comply with corporate engineering standards, environmental regulations, food safety requirements, and applicable industry codes.
- Promote continuous improvement and standardization of yogurt processing technologies across the global manufacturing network.
- Travel to domestic and international manufacturing sites, vendor locations, and corporate offices as necessary to support project planning, execution, and commissioning.
Requirements
From your STORY to ours
Qualified applicants will contribute the following:
Education
- Bachelor's degree is required.
- A major in Food, Chemical, Mechanical, or Industrial Engineering is required.
Experience
- 8+ years working on Capital Expenditure, managing multi-million-dollar projects is required. Corporate or multi-site project management experience is preferred.
- 8+ years of experience in the Dairy, Beverage, or Liquid Food Manufacturing industry is required.
- 5+ years of experience in a USDA or FDA regulated industry is required
Certifications and specific knowledge
- The following certification is recommended for this role: Project Management Professional certification.
- Knowledge of Capital Project Management tools (Project Initiation, Stage-gate, Risk Management, Cost Tracking, FAT/SAT protocol Development and Execution, Project Closure) is required.
- Knowledge of Contract Management and Vendor Management are required.
- Knowledge of Food Safety & Regulatory requirements (Pasteurized Milk Ordinance, Sanitary Design, 3-A Standards, cGMP, Microbiological control) is required.
- Understanding of Dairy Process unit operations (Separation, Standardization, Pasteurization, Homogenization, Fermentation, etc.) is required.
- Knowledge of Mass & Energy Balances and Process Modeling is required.
- Knowledge of Tank and Piping design (including agitation, heat transfer, hygienic fittings, pumps, valves) is required.
- Understanding of Production Lines, OEEs, Capacity & Saturation calculations, and integration with upstream process equipment is an asset.
- Understanding of process Automation & Controls (PLC, Scada, MES, Batch and Recipe management) is a plus.
- Knowledge of MS Office applications, MS Project, and AutoCAD is required. Knowledge of Excel pivot tables and macros is preferred.
Work Conditions
- Travel is required up to 75% monthly.
- Extended hours may be necessary depending on the project needs
- To fulfill these responsibilities, tools such as a computer, phone or, and / or allowance(s) will be provided.
- Reasonable accommodations may be made to enable individuals with disabilities to perform these essential duties and responsibilities.
- This position requires physical presence in the office, in accordance with the guidelines of the Hybrid Work Policy.
At Lactalis, we offer a comprehensive Total Rewards Program with a variety of affordable benefits and coverage options. We support insurance costs significantly, contribute generously to retirement plans, and offer Paid Time Off from day one. We are committed to your professional growth, providing training and development opportunities, including Education Reimbursement. Join us and grow your career.
Lactalis is an equal employment opportunity employer. We will not discriminate against applicants with regard to any legally-recognized basis including, but not limited to: veteran status, race, color, religion, sex, national origin, age, marital status, sexual orientation, and physical or mental disabilities. Further, any division of the Company that is an Affirmative Action Employer will comply with all related legal obligations
Description
Ready for more than just a job? Build a career with purpose.
At Lactalis in the USA, we're committed to providing meaningful opportunities for our people to learn, grow, and thrive-whether you're just starting your journey with us or looking to take the next step in your career. From day one, we offer the tools and support to help you succeed.
As the world leader in dairy, Lactalis is a family-owned company with over 85,000 pragmatic and ambitious professionals across the globe. Each day, we're proud to produce award-winning dairy products that bring people together.
In the US, we proudly offer an unrivaled house of beloved brands, including Galbani Italian cheeses and ricotta, President specialty cheeses and butters, Kraft natural and grated cheeses, Breakstone's cottage cheese, Cracker Barrel, Black Diamond cheddar, and Parmalat milk. Our yogurt portfolio includes siggi's, Stonyfield Organic, Brown Cow, Oui, Yoplait, Go-Gurt, :ratio, Green Mountain Creamery, and Mountain High, along with a growing family of ethnic favorites like Karoun, Gopi, and Arz.
At Lactalis, we live by our core values-Ambition, Engagement, and Simplicity. We foster a workplace where innovation thrives, diverse perspectives are celebrated, and everyone's unique background and ideas are valued.
Even if you don't meet every qualification, we encourage you to apply. We want to hear about your PASSION, your STORY, and how your EXPERTISE can help us shape the future of dairy.
From your PASSION to ours
Lactalis USA, part of the Lactalis family of companies, is currently hiring a Sr. Process Project Manager based in Londonderry, New Hampshire. As a Senior Process Project Manager, the role will carry out responsibilities such as but not limited to leading and executing strategic capital investment and process improvement projects that enhance the design, performance, and reliability of our yogurt manufacturing operations. The role includes overseeing projects from concept through full implementation, ensuring alignment with corporate standards, plant operational needs, and product quality expectations. Responsibilities include driving process design, managing cross-functional project teams, supporting production and quality operations, and ensuring successful commissioning of new or upgraded yogurt processing systems. Additionally, the Senior Yogurt Process Project Manager will collaborate with other Lactalis USA Corporate team members, the Lactalis Group Corporate Engineering & Equipment Department, R&D, Quality, Finance, and Plant Engineering and Operations teams to align duties with the company's goals and values.
- Define project objectives, deliverables, and performance criteria to support strategic business goals within yogurt manufacturing and processing.
- Conduct site assessments and feasibility studies to evaluate technical constraints, operational impacts, and cost-benefit considerations.
- Partner with Key Stakeholders at Corporate and Plant level - including Production, Quality, Planning, R&D, Finance, Safety, Maintenance, and Engineering - to obtain buy-ins and to ensure that project designs meet business, operational, and regulatory expectations.
- Develop complete project packages including process flow diagrams, P&IDs, equipment layouts, scopes of work, cost estimates, timelines, ROI, and risk assessments required for capital project justification and submittal.
- Identify, evaluate, and prequalify suppliers, engineering firms, and equipment vendors aligned with corporate standards and yogurt processing technology requirements.
- Lead vendor negotiations to secure competitive quotations for capital assets, installation services, and engineering support.
- Prepare comparative analyses and recommendations for purchasing decisions and capital investment approvals.
- Lead end-to-end project management for yogurt process initiatives, from conceptual design through commissioning, ramp up, project closure, and handover.
- Maintain and distribute comprehensive Project Schedules, identify critical paths, implement mitigation initiatives, and propose acceleration plans to ensure all projects are completed in accordance with the timelines in the Savings Plans and ROI calculations.
- Coordinate and facilitate project review meetings, develop and distribute meeting minutes, and escalate issues or risks to key stakeholders as required.
- Attend Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and commissioning activities to ensure equipment performance aligns with specifications and project objectives.
- Oversee installation, startup, and optimization of yogurt processing systems, resolving technical issues and ensuring seamless integration with existing operations.
- Ensure all projects comply with corporate engineering standards, environmental regulations, food safety requirements, and applicable industry codes.
- Promote continuous improvement and standardization of yogurt processing technologies across the global manufacturing network.
- Travel to domestic and international manufacturing sites, vendor locations, and corporate offices as necessary to support project planning, execution, and commissioning.
Requirements
From your STORY to ours
Qualified applicants will contribute the following:
Education
- Bachelor's degree is required.
- A major in Food, Chemical, Mechanical, or Industrial Engineering is required.
Experience
- 8+ years working on Capital Expenditure, managing multi-million-dollar projects is required. Corporate or multi-site project management experience is preferred.
- 8+ years of experience in the Dairy, Beverage, or Liquid Food Manufacturing industry is required.
- 5+ years of experience in a USDA or FDA regulated industry is required
Certifications and specific knowledge
- The following certification is recommended for this role: Project Management Professional certification.
- Knowledge of Capital Project Management tools (Project Initiation, Stage-gate, Risk Management, Cost Tracking, FAT/SAT protocol Development and Execution, Project Closure) is required.
- Knowledge of Contract Management and Vendor Management are required.
- Knowledge of Food Safety & Regulatory requirements (Pasteurized Milk Ordinance, Sanitary Design, 3-A Standards, cGMP, Microbiological control) is required.
- Understanding of Dairy Process unit operations (Separation, Standardization, Pasteurization, Homogenization, Fermentation, etc.) is required.
- Knowledge of Mass & Energy Balances and Process Modeling is required.
- Knowledge of Tank and Piping design (including agitation, heat transfer, hygienic fittings, pumps, valves) is required.
- Understanding of Production Lines, OEEs, Capacity & Saturation calculations, and integration with upstream process equipment is an asset.
- Understanding of process Automation & Controls (PLC, Scada, MES, Batch and Recipe management) is a plus.
- Knowledge of MS Office applications, MS Project, and AutoCAD is required. Knowledge of Excel pivot tables and macros is preferred.
Work Conditions
- Travel is required up to 75% monthly.
- Extended hours may be necessary depending on the project needs
- To fulfill these responsibilities, tools such as a computer, phone or, and / or allowance(s) will be provided.
- Reasonable accommodations may be made to enable individuals with disabilities to perform these essential duties and responsibilities.
- This position requires physical presence in the office, in accordance with the guidelines of the Hybrid Work Policy.
At Lactalis, we offer a comprehensive Total Rewards Program with a variety of affordable benefits and coverage options. We support insurance costs significantly, contribute generously to retirement plans, and offer Paid Time Off from day one. We are committed to your professional growth, providing training and development opportunities, including Education Reimbursement. Join us and grow your career.
Lactalis is an equal employment opportunity employer. We will not discriminate against applicants with regard to any legally-recognized basis including, but not limited to: veteran status, race, color, religion, sex, national origin, age, marital status, sexual orientation, and physical or mental disabilities. Further, any division of the Company that is an Affirmative Action Employer will comply with all related legal obligations.
Job Title: Director Process Development and Manufacturing, CMC
Department: CMC
Reports to: Chief Technical Officer
About the Company:
Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.
Job Summary:
The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization. This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas.
Duties/Responsibilities:
· Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply.
· Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.
· Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc.
· Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.
· Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites.
· Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.
· Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies.
· Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages.
· Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.
· Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.
Supervisory Responsibilities:
· None
Education and Experience:
· Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.
· Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.
· Experience designing and executing technical transfer and scale up campaigns and associated documentation.
· Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs.
· Experience with FDA and/or other regulatory agency requirements and interactions.
· Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.
· Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.
· Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.
· Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.
· Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).
Physical Requirements:
· Ability to travel 20% of time
· Ability to work in laboratory settings/situations
· Prolonged periods sitting at a desk and working on a computer.
· Must be able to lift up to 15 pounds at times.
Location:
This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.
Salary Range:
$190,000-210,000
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
This is a six month assignment in Vacaville
This potsition is for local candidates as there is no travel and living expenses
This is a W2 Position.
Process Engineer I
Summary:
This position is located at Lonza’s production facility in Vacaville, California. The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques. This temporary contract position provides hands-on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility. PAT systems play a critical role in monitoring mammalian cell culture processes by measuring key parameters such as cell density, viability, and metabolite concentrations. Maintaining these systems in a reliable, ready-to-use state is essential for ensuring consistent manufacturing performance.
In this role, you will support day-to-day operation, maintenance, and troubleshooting and repair of PAT instruments used in GMP manufacturing. You will work closely with the Frontline Upstream (FLUS) System Owner, Manufacturing, and Instrumentation staff to assess system issues, perform equipment health checks, execute planned improvements, and assist with investigations into unplanned events. This position supports the increased workload associated with the deployment of several new PAT systems in parallel with existing instruments. This position offers the opportunity to gain hands-on experience with advanced PAT used to support mammalian cell culture and purification operations. The FLUS and Instrumentation groups provide technical support for a wide range of analytical instruments used to monitor cell growth, metabolite profiles, and process performance throughout the manufacturing lifecycle.
Job Duties:
Responsibilities/activities may include, but not limited to:
• Performing routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).
• Supporting manufacturing operations by responding to system-related issues, troubleshooting instrument performance, and documenting observed problems.
• Assisting in the investigation of unplanned equipment events using structured problem-solving tools and contributing to root cause assessments.
• Conducting equipment health monitoring and contributing to reliability improvement activities to increase system uptime.
• Executing planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.
• Reviewing and interpreting instrument data to identify basic trends or abnormalities.
• Supporting adherence to data integrity principles and helping maintain data consistency within systems such as Smartline Data Cockpit.
• Collaborating with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.
• Assisting with documentation updates, tracking of work activities, and preparing technical summaries as needed.
• Working independently to accomplish assigned tasks while keeping stakeholders informed of progress.
Education and Experience:
• B.S., M.S., or Ph.D in an engineering or analytical/scientific discipline.
• Prior hands-on experience with analytical systems is required.
• Experience using cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) in GMP Manufacturing or QC Labs preferred.
Knowledge/Skills/Competencies:
• Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.
• General understanding of biotech analytical methods and laboratory practices.
• Experience troubleshooting analytical instruments and interpreting equipment performance data.
• Flexibility in problem solving and work hours to meet business objectives.
• Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.
• Strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.
• Ability to work independently and manage assigned tasks with limited supervision.
• Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.
• Strong verbal and written communication skills, including documentation, reporting, and stakeholder updates.
• Ability to build productive working relationships with end users and equipment vendors.
• Strategic thinking mindset with the ability to convert system needs into actionable activities.
• Builds productive relationships with partners; focuses on customer needs.
Clinical Data Scientist
Redwood City, CA (Hybrid potentially remote options)
Salary: $150,000-$190,000
No Sponsorship Available
About the Role
We are seeking a Clinical Data Scientist to play a pivotal role in transforming complex clinical datasets into high‑quality, analysis‑ready outputs used to support clinical trials and real‑world evidence initiatives.
In this role, you will operate at the intersection of data science, clinical research, and statistical programming. You’ll be responsible for validating, cleaning, and structuring data originating from multiple sources—including expert manual abstraction teams, AI‑assisted pipelines, EMR feeds, and EDC systems.
You’ll collaborate closely with Clinical Operations, Data Engineering, and AI/ML teams to ensure accuracy, traceability, and compliance across every dataset delivered internally or externally.
This role is ideal for someone who is detail‑obsessed, technically versatile, and passionate about elevating the quality of clinical data used in drug development.
What You’ll Do
- Convert raw, manually abstracted, and AI‑processed datasets into standardized formats (e.g., CDISC SDTM/ADaM) or client‑specific data models.
- Ensure outputs meet quality, compliance, and traceability standards.
- Generate TLFs (Tables, Listings, Figures) for clinical reports and interim analyses using SAS, R, or Python.
- Perform robust data cleaning and QC checks.
- Investigate anomalies and troubleshoot issues across the data pipeline.
- Distinguish between upstream extraction issues and true clinical variations.
- Partner with Data Platform and AI teams to automate cleaning scripts, validations, and workflow logic.
- Serve as an early user and feedback partner for internal data tools.
- Maintain documentation for data derivations, specifications, and validation logic (e.g., Define.xml, Reviewers Guides).
- Support compliance and regulatory submission needs.
- Complete internal and external analysis requests to support clinical insights, client value, and platform performance.
- Apply HIPAA-aligned data safeguards and adhere to best practices across privacy, security, and data governance.
What You Bring
- Education:
- BSc/MSc in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
- Experience:
- 2–5+ years in clinical data science, statistical programming, or data management in pharma/biotech.
- Technical Strengths:
- SAS, R, Python, SQL
- Experience with Git/version control preferred
- Industry Knowledge:
- Familiarity with clinical trial workflows
- Strong understanding of CDISC SDTM/ADaM
- Oncology endpoints (RECIST, survival) and RWD experience is a plus
- Data Wrangling:
- Comfort “stitching together” messy, real‑world clinical datasets
- Experience with unstructured text or NLP outputs is desirable
- Soft Skills:
- Exceptional attention to detail
- Clear, structured communicator
- Proactive, self‑directed, collaborative
JOB DESCRIPTION: We are seeking a highly motivated, analytical, and accountable Senior Supply Planner to execute day-to-day supply and material planning activities. This person will be responsible for developing, executing, and continuously improving supply plans to support customer demand, operational targets, and inventory strategies. This role serves as the planning subject matter expert, driving cross-functional alignment between demand planning, manufacturing, logistics, finance, and commercial teams to ensure product availability, optimize working capital, and mitigate supply risk.
JOB RESPONSIBILITIES:
Supply Planning & Execution
- Develop, manage, and optimize supply plans for finished goods and raw materials
- Review demand forecasts, production capacity, lead times, and constraints to generate feasible supply plans
- Issue PO’s and manage rolling 12 month production forecasts to suppliers
- Input item receipts and PO changes into NetSuite
- Drive root cause analysis and resolution of supply issues, including shortages, delays, and excess inventory
- Maintain appropriate safety stock levels across DC network to balance service and cost
- Monitor inventory health, slow-moving items, and obsolescence risk; recommend corrective actions
Cross-Functional Collaboration
- Partner with Demand Planning, Suppliers, Sourcing, and Sales to align supply with business priorities
- Participate in S&OP, presenting supply risk, opportunities, and recommendations
- Collaborate with logistics to ensure the timeliness of supplier production to DC delivery
Analytics & Reporting
- Track KPIs such as fill rate, inventory turns, E&O / SLOB, achievement, and adherence
- Calculate and present inventory and cut projections
- Analyze trends, develop insights, and create dashboards or reports for leadership
- Support continuous improvement and planning initiatives
Other
- Serve as a planning lead in any software or EDI implementations
- Ensure integrity of related data within NetSuite (orders, BOMs, item receipts, etc.)
- Ad hoc projects and analyses as needed
JOB QUALIFICATIONS:
- Bachelor’s degree in Supply Chain Management or a related field
- Minimum of 3 years of experience in supply planning, materials planning, inventory management, or a related role, within the consumer goods industry. A combination of startup and corporate experience is highly valued.
- Understanding of E2E supply chain, and upstream/downstream impacts this role has
- Strong analytical and problem-solving skills with the ability to interpret complex data and translate it into actionable insights
- Very organized and able to keep track of information communicated via various modes (emails, Slack, meetings, etc.)
- Demonstrated success in managing supply risk and influencing cross-functional stakeholders
- Responsible and accountable, with the ability to continuously follow up as needed
- Expert proficiency in Microsoft Excel and Google Sheets (advanced formulas, pivot tables/charts, data analysis, macros, etc.)
- Experience with planning software and/or ERP systems (NetSuite, SAP, etc.)
- Ability to thrive in a fast-paced, dynamic, and often ambiguous startup environment; flexibility to change directions as needed
As a Data Steward Senior Analyst, you are part of a team responsible for enabling and supporting compliance with data-related enterprise policies within their domains/business units. You and your team are responsible for identifying critical data and associated risks, maintaining data definitions, classifying data, supporting data sourcing / usage requests, measuring Data Risk Controls, and confirming Data Issues are remediated. You have the opportunity to partner across various business units, technology teams, and product/platform teams to define and implement the data governance strategy, supervising and leading data quality, resolving data/platform issues, and driving consistency, usability, and governance of specific product data across the enterprise.
In addition, this role will play a key part in effectively communicating new and updated data-related policies to the teams responsible for compliance. The individual must be skilled in preparing clear, engaging presentations that translate formal policy language into practical, easy-to-understand guidance and “tell the story” behind the policy requirements. The role will also support the delivery of training sessions, facilitate policy office hours, and serve as a go-to resource for questions related to data governance and retention compliance.
Your Primary Responsibilities may include:
• Assist in identifying data-related risks and associated controls for key business processes. Risks relate to Record Retention (primary), Data Quality, Data Movement, Data Stewardship, Data Protection, Data Sharing, among others.
• Develop training materials and educate organization on Record Retention and Deletion processes and procedures.
• Develop deep understanding of key enterprise data-related policies and serve as the policy expert for the business unit, providing education to teams regarding policy implications for business.
• Collaborate with and influence product managers to ensure all new use cases are managed according to policies.
• Influence and contribute to strategic improvements to data assessment processes and analytical tools.
• Support current regulatory reporting needs via existing platforms, working with upstream data providers, downstream business partners, as well as technology teams.
• Subject matter expertise on multiple platforms.
• Responsible to partner with the Data Steward Manager in developing and managing the data compliance roadmap.
Qualifications include:
• 5 + years of experience in a similar role involved with ensuring compliance with Record Retention and Deletion policies.
• Strong communication skills and ability to influence and engage at multiple levels and cross functionally.
• Intermediate understanding of Data Management and Data Governance concepts (metadata, lineage, data quality, etc.) and prior experience.
• 5+ years of Data Quality Management experience.
• Strong familiarity with data architecture and/or data modeling concepts
• 5+ years of experience with Agile or SAFe project methodologies
• Bachelor’s degree in Finance, Engineering, Mathematics, Statistics, Computer Science or other similar fields.
• Preferred: Experience in Travel Industry.
• Preferred: Knowledge of RCSA (Risk Control Self-Assessment) methodology
Leadership Skills may include:
• Makes Decisions Quickly and Effectively: Drives effective outcome through decision making authority. Displays judgement and discretion in order to ensure deliverables are sufficient to the American Express policy and overall compliance.
• Drives Innovation & Change: Provides systematic and rational analysis to identify the root cause of problems. Is prepared to challenge the status quo and drive innovation. Makes informed judgments, recommends tailored solutions.
• Leverages Team - Collaboration: Coordinates efforts within and across teams to deliver goals, accountable to bring in ideas, information, suggestions, and expertise from others outside & inside the immediate team.
• Communication: Influences and holds others accountable and has ability to convince others. Identifies the specific data governance requirements and is able to communicate clearly and in a compelling way.
- 3rd Shift: 12:00 AM – 8:00 AM | Sunday – Thursday In-person interviews required for Machine Maintenance Technician We are seeking a hands-on Machine Maintenance Technician to support production operations by maintaining and repairing manufacturing equipment.
This role is responsible for troubleshooting machine breakdowns, performing preventative maintenance, and ensuring production equipment runs efficiently with minimal downtime.
This position is ideal for candidates with mechanical maintenance experience in manufacturing, automotive repair, HVAC, machining, or industrial equipment maintenance.
Key Responsibilities for Machine Maintenance Technician Troubleshoot and repair mechanical equipment breakdowns Diagnose and resolve speed, performance, and waste issues Perform preventative maintenance on production equipment Set up, operate, optimize, and maintain assigned production machines Perform equipment changeovers and adjustments Monitor machines and ensure proper operation within quality and production standards Document downtime and maintenance activities in equipment logs Maintain a clean and safe production environment Support upstream and downstream production operations Assist maintenance team with larger equipment repairs as needed Required Skills (Must Have) for a Machine Maintenance Technician Candidates must have the following skills to be considered: Strong mechanical troubleshooting experience Experience using feeler gauges and measurement tools for tolerances, torque, and clearances Knowledge of mechanical components including: cams and cam-followers rod ends and bushings chain drives and conveyors gearboxes pneumatic systems vacuum systems ball valves Ability to lift up to 50 lbs and push/pull up to 100 lbs Preferred Backgrounds for Machine Maintenance Technician Candidates with experience in the following fields are strongly encouraged to apply: Industrial Maintenance Technician Mechanical Technician Automotive / Diesel Mechanic HVAC Technician Machinist Production Equipment Technician Small Engine or Marine Mechanic Experience with high-speed manufacturing or automated production equipment is a plus.
Additional Responsibilities for Machine Maintenance Technician: Maintain equipment within specified quality and production limits Start up machines and verify proper functionality Monitor and replenish machine components and materials Clear jams and restart machine cycles safely Perform quality checks and process verification Follow all safety, environmental, and quality system procedures Work collaboratively in a team-oriented environment focused on continuous improvement Education for a Machine Maintenance Technician High School Diploma or GED required.
Vision Requirement for Machine Maintenance Technician An eye exam will be required after a conditional offer of employment.
This role requires: 20/30 vision with or without corrective lenses , and/or Successful completion of a color vision exam
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