Gap Inc Remote Work Jobs in Usa
286 positions found — Page 3
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary US Medical Affairs leader for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA).
Develops the USOMA strategy and tactical plan as part of the US Brand Strategic Plan and leads the execution of the activities in the USOMA plan including Launch Readiness and Life Cycle Management.
Leads the team for this compound.
Job Description Responsibilities Responsible for the development of the USOMA strategy and medical objectives for the assigned compound and leads development and execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Participates in Global Medical Affairs committees as requested.
Serves as US Medical Affairs Lead, to gain strategic and planning alignment across the matrix team and the core USOMA functions.
Represents US medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions.
Provides medical leadership: oLeads USOMA teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed.
Partners with RWE and HEOR strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the USOMA Plan.
Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a US IIS Review Committee, for assigned compound.
oCollaborates with Global Medical Affairs and across USOMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations.
Leads internal stakeholder medical education activities related to the compound data.
In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data.
oProvides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders.
Provides medical support for scientific symposium and medical congresses within legal and compliance regulations.
oWorks with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively.
oProvides input into publication strategy, data gap analysis, and tactical planning as part of the overall USOMA plan.
Reviews and approves abstracts, manuscripts, and other data disclosure documents.
Attract and develop USOMA talent.
Provides coaching, direction, feedback and guidance as needed.
Evaluate team progress against goals/objectives.
Manage budgets and resources efficiently for USOMA supported activities within the USOMA plan, is required.
Experience in collaboration with US Oncology Franchise Head oncology therapeutic area is required Responsibilities Continued Qualifications Education Qualifications An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area required MD preferred Experience in oncology therapeutic area required Experience Qualifications 10 or More Years Pharmaceutical industry experience or commensurate healthcare or research experience required and 4 or More Years Minimum of 5 years of (in-house) medical affairs or related experience, US preferred required and • Must have oncology experience, specifically in solid tumors.
• Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities • Demonstrated ability to lead and influence others internally and externally • Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g.
US Product Team, US Brand Team, Global Medical Team, etc.) • Relationships with or proven history developing key external experts • Proven ability to manage multiple priorities at one time required and •Knowledge of ADC or other biologics, or small molecules •Demonstrated experience working with an alliance partner company preferred Travel Requirements Ability to travel up to 20% of the time.
Additional Information Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range: USD$230.175,00
- USD$383.625,00 Download Our Benefits Summary PDF
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary Medical Affairs Diagnostic lead, under leadership of the Executive Director of Research and Strategy, US Oncology Medical Affairs.
Develops and implements the USMA diagnostic strategy and tactical plan for all therapeutic areas as part of the US Brand Strategic Plan and leads the execution of the activities in the USMA plan including Launch Readiness and Life Cycle Management.
Responsibilities Responsible for the development of the US Medical Affairs strategy and medical objectives for all compounds and leads development, execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective.
Participates in Global Medical Affairs committees as requested and processes as US Medical Affairs Lead, to gain strategic and planning alignment across the matrix team the core USMA functions.
Represents US medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions.
Provides medical leadership: oLeads USMA teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed.
Partners with RWE and HEOR strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the USMA Plan.
oCollaborates with Global Medical Affairs and across USMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations.
Leads internal stakeholder medical education activities related to the compound data.
In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data.
oProvides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders.
Provides medical support for scientific symposium and medical congresses within legal and compliance regulations.
oWorks with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively.
oProvides input into publication strategy, data gap analysis, and tactical planning as part of the overall USMA plan.
Reviews and approves abstracts, manuscripts, and other data disclosure documents.
Manage budgets and resources efficiently for USOMA supported activities within the USMA plan, in collaboration with US Oncology Franchise Head Qualifications Education Qualifications Advanced scientific degree (Ph.D., PharmD or MD), equivalent will be considered with relevant experience in a health sciences related field or an equivalent combination of education and experience required Bachelor's Degree required Experience Qualifications 10 or More Years Pharmaceutical industry experience or commensurate healthcare or research experience required 4 or More Years Post-doctoral and/or relevant industry experience, and expertise in oncology biomarker and/or companion diagnostic development required 4 or More Years (in-house) medical affairs or related experience, US preferred required •Must have oncology experience, specifically in solid tumors •Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities •Demonstrated ability to lead and influence others internally and externally -Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g.
US Product Team, US Brand Team, Global Medical Team, etc.) -Relationships with or proven history developing key external experts • Proven ability to manage multiple priorities at one time • Strong knowledge of medical strategy, clinical diagnostic development, and Field Medical activities required •Knowledge of ADC or other biologics, or small molecules •Demonstrated experience working with an alliance partner company preferred Travel Requirements Ability to travel up to 20% of the time.
Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range: USD$230.175,00
- USD$383.625,00 Download Our Benefits Summary PDF
DataStaff, Inc. is currently seeking a Software Tester/QA Analyst for a long-term contract opportunity with one of our direct clients in Richmond, VA.
*This position is hybrid
Job Description:
Our client is seeking a QA Analyst to ensure product quality by creating comprehensive test coverage and automated test scripts that support integration and faster releases. This role strengthens defect prevention, improves reliability, and reduces manual testing across the Agile processes.
Responsibilities
- Test Case Design and Documentation - Develop detailed, traceable, and reusable test cases based on business requirements, user stories, acceptance criteria, and system workflows.
- Test Planning and Execution - Participate in test planning, identify test scenarios, execute manual tests when needed, and document results.
- Automation Framework Development - Build, maintain, and enhance automation frameworks using approved tools and technologies (e.g., preferably Playwright).
- Automated Test Script Creation - Write, optimize, and maintain automated test scripts for regression, smoke, and functional testing.
- Defect Identification and Reporting - Log defects with clear reproduction steps, severity, and impact; collaborate with developers to validate fixes.
- Continuous Integration Support- Integrate automated tests into CI/CD pipelines (e.g., DevOps, Jenkins, GitLab CI).
- Quality Metrics and Reporting - Provide regular reporting on test coverage, defect trends, and automation progress.
- Collaboration - Work closely with agile team, business analysts, developers, product owners, and project managers to ensure alignment on requirements and quality expectations.
Knowledge and Experience:
- Understanding of SDLC, Agile methodologies, and QA best practices.
- Ability to analyze requirements and identify gaps or ambiguities.
- Strong documentation, communication, and problem‑solving skills.
- Experience with performance testing tools (JMeter, LoadRunner).
- Knowledge of BDD frameworks (Cucumber, SpecFlow).
- Exposure to Oracle and APEX based system test and financial system is a plus.
- ISTQB or similar QA certification.
- Automated regression suite with measurable coverage.
- Complete set of manual test cases mapped to requirements.
- Test execution reports and defect logs.
- Documentation for automation framework and test scripts.
- Ongoing maintenance of test cases and automation assets.
Required Skills:
- 7 Years - Strong experience writing manual test cases and converting them into structured test suites.
- 5 Years - Hands-on experience with test automation tools is required (preferably Playwright).
- 4 Years - Proficiency in programming/scripting languages used for automation (Java, Python, JavaScript, C#, etc.).
- 3 Years - Familiarity with CI/CD pipelines and version control (Git).
Desired Skills:
- 3 Years - Experience with API testing using tools like Postman, RestAssured, or similar.
- 3 Years - Experience with performance testing tools (JMeter, LoadRunner).
- 2 Years - Knowledge of BDD frameworks (Cucumber, SpecFlow).
- 2 Years - Exposure to Oracle and APEX based system test and financial system.
This position is available on a corp to corp basis or as a W2 position with a competitive benefits package. DataStaff offers medical, dental, and vision coverage options as well as paid vacation, sick, and holiday leave. As many of our opportunities are long-term, we also have a 401k program available for employees after 6 months.
Associate Manager, Compliance - III*
Santa Monica, CA
18 Months
- The Associate Director, Evidence Generation Compliance is responsible for ensuring that all evidence-generating activities (e.g., observational research, clinical outcomes studies, RWE initiatives, investigator-sponsored research, and collaborative research programs) are executed in accordance with internal policies, regulatory requirements, and industry best practices. This role safeguards audit readiness, strengthens governance, and drives consistency and rigor in processes and documentation across the Evidence Generation function.
- The ideal candidate is a detail-oriented compliance leader experienced in medical affairs operations, governance, and documentation management, with the ability to collaborate across cross-functional teams and influence best practices globally.
Key Responsibilities:
Audit Readiness & Documentation Excellence
- Ensure all Evidence Generation documentation is consistently audit ready, complete, current, and compliant with internal standards and external regulatory expectations.
- Conduct periodic quality checks and systems-of-record reviews across programs and studies to proactively identify gaps and areas for improvement.
- Partner with functional leads and study owners to support robust, accurate, and timely documentation practices.
SOP Reinforcement, Maintenance, and Training
- Reinforce adherence to Standard Operating Procedures (SOPs), Work Instructions, and controlled documents across Evidence Generation and Medical Affairs.
- Lead the update, revision, and creation of SOPs as needed, ensuring alignment with evolving regulatory guidelines and industry best practices.
- Develop and deliver targeted training programs to strengthen compliance awareness and procedural consistency across teams.
Governance & Process Oversight
- Manage and continuously improve Evidence Generation governance documentation, ensuring version control, accessibility, and alignment with organizational quality frameworks.
- Support governance body operations (e.g., review committees, oversight boards) by preparing materials, maintaining records, and ensuring compliant decision-making processes.
- Ensure all proposals, concepts, and new study requests are reviewed by the appropriate governance body in a timely and compliant manner, including triage of submissions, coordination of review schedules, and communication of outcomes to stakeholders.
- Implement and monitor compliance KPIs, metrics, and dashboards to ensure ongoing transparency and operational excellence.
Cross-Functional Collaboration
- Partner with Legal, Compliance, Regulatory, and Quality Assurance to ensure holistic alignment and timely issue resolution.
- Provide compliance guidance during planning and execution of evidence generation activities, including protocol development, contracting, data sharing, authorship, and publication processes.
Continuous Improvement
- Identify opportunities to streamline workflows, reduce procedural burden, and enhance operational efficiency while maintaining compliance rigor.
- Support change management efforts, including communication planning and stakeholder alignment, for new or updated processes.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Cleaning Validation Engineer
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Hubot Tri-Pac, Inc South Bend, Indiana, United States (On-site)
Hubot |Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Validation Engineer.
Job Description
The Cleaning Validation Engineer will demonstrate his/her knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes and work independently in a matrix team environment, influencing team decisions, and exercising sound judgement in determining compliant and robust validation approaches. He/she will have the ability to multi-task with a demonstrated track record in meeting deliverable timelines and must demonstrate the ability to think critically and analytically with acumen for troubleshooting and problem solving and is a strong team player aligned with company corporate values. Will have good interpersonal, verbal, and written communication skills and has the ability to function effectively and independently in a fast-paced and dynamic environment. He/she is self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed. Has the ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs. Is an expert with Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills and understands basic statistics, acceptance sampling, and is familiar with statistics software. Demonstrates hands on experience with facility/equipment/utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment and with CIP/SIP cycle development.
Responsibilities
- Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP/SIP qualification), cleaning validation, computer system validation and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis
- As needed coordinate and provide directions to contract personnel performing validation activities
- Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort
- Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports
- Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization) development activities
- Support periodic requalification and revalidation effort
- Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA
- Support gap assessment/closure, corrective actions, and compliance remediation related to Validation
- As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections
- As assigned mentor and manage fulltime validation engineers/specialist and contractors
Education And/or Experience
- Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus
- Minimum 5+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 3 of 7 validation core expertise
- Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation
- Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820)
- Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, and applicable PDA Technical Reports)
- Experience with customer and regulatory inspection
- Strong understanding of quality risk management principles, including best practice in risk-based C&Q approach
- Hands on validation experience in developing validation documentation and field execution
- Project Management experience is a plus
- Aerosol production experience is a plus
Benefits
Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.
you for your interest and consideration of a career with Tri-Pac, Inc.
Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer
Topa Group, Inc is partnered with a commercial Electrical Contractor in the Austin area. We are looking to hire an Electrical Estimator.
Position Overview
The Electrical Estimator will be responsible for preparing accurate and competitive cost estimates for commercial electrical projects, supporting business development efforts, and working closely with project managers and operations teams.
Responsibilities
- Prepare detailed electrical estimates for commercial projects
- Perform take-offs and pricing using Accubid
- Review drawings, specifications, and bid documents
- Solicit and analyze vendor and subcontractor pricing
- Identify risks, value-engineering opportunities, and scope gaps
- Collaborate with project management and operations teams during bid handoff
- Maintain organized estimate documentation and historical cost data
Required Qualifications
- Proven experience as an Electrical Estimator for a commercial electrical contractor
- Strong proficiency with Accubid
- Deep understanding of commercial electrical systems and construction methods
- Ability to read and interpret plans, specs, and addenda
- Strong analytical, organizational, and communication skills
- Ability to manage multiple bids and deadlines simultaneously
Compensation & Benefits
- Salary commensurate with experience
- Medical, Dental, and Vision insurance
- 401(k) retirement plan
- Stable, long-term opportunity with a reputable contractor
Position Title: Production Manager
Reports To: Plant Manager
FLSA Status: Exempt
Can you make the AGC Difference? AGC Heat Transfer, Inc. is looking for a dynamic manufacturing Production Manager to support the company's mission to provide reliable, innovative plate heat exchanger products, solutions and services that surpass expectations of food manufacturers.
Brief Company Description
AGC Heat Transfer, Inc., is the leading OEM of sanitary plate heat exchangers in North America, manufacturing plate heat exchangers specifically designed for sanitary applications. AGC offers complete heat exchangers, services as well as upgrades to plate packs, gaskets and spares that fit multiple brands. In addition, AGC offers Field Leak Testing and inspections of plate heat exchangers that meet the 3-A sanitary standard.
AGC Heat Transfer consists of four manufacturing/service facilities (Bristow, VA, Fairview, OR, Pleasant Prairie, WI & Fort Worth, TX) with about 125 employees (78 OR / 20 VA / 28 other locations). AGC Heat Transfer has a strong engineering culture with a heavy emphasis on customer service and technical/consultative sales.
Job Description
The Production Manager assists the Plant Manager by coordinating the activities of employees within the production facility. The Production Manager will oversee the daily plant operations of the Fairview plant, including training and mentoring of plant supervisors as well as coordinate activities internal to the plant and outside the organization (suppliers and customers) to meet production requirements.
This role utilizes knowledge of equipment, policies, procedures and specifications to maintain production schedules and ensures that the team adheres to all standards and performance requirements including quality, delivery, and above all safety.
Position Responsibilities
The Production Manager will perform the following duties and other special projects as required:
- Coordinate and support the daily work schedule of the plant
- Develop processes and performance standards for the supervisor team
- Define KPIs (Key Performance Indicators) for each department
- Work and align all plant departments within the company’s (both production and support) overall business goals.
- Close competence gaps by training/ coaching and using Standard Operating Procedures (SOP’s) and Job Instructions (JIB’s).
- Generate required quality documentation.
- Control of quality, deviations, and productivity together with Plant Manager.
- Focus on waste elimination and process improvements.
- Drive meetings with department supervisors.
- Develop and maintain production schedules for the plant operation to meet lead times.
- Lead problem solving exercises when issues arise within production.
- Facilitate reviews and job development of plant supervisors.
- Would fill in for Plant manager duties when out of plant.
- Other specifically assigned tasks where needed by the Company.
- All other duties assigned.
Key Competencies
- High Integrity with a commitment to honesty, trust and transparency.
- Displays Care embracing the highest standards to ensure resource efficiency for the well-being of team members and responsibility to the environment.
- Innovative and curious promoting diversity of thought while understanding the needs of the customer leveraging cutting-edge technology utilizing state-of-the-art processes.
- Committed to Excellence through perseverance, GRIT and a focus on continuous improvement consistently delivering quality equipment, parts and service of unmatched value.
- Execution while focusing on quality, safety and Teamwork delivering results motivated by a diverse and inclusive culture based on accountability, customer/employee satisfaction, creative solutions, and constant communication.
- Enthuses others and facilitates successful Goal accomplishment by promoting a clear sense of purpose, inspiring a positive attitude to work, and arousing a strong desire to succeed among team members.
- Provides team with clear directions, organizes resources and Leads others towards successful task accomplishment.
Skills & Qualifications
- High school diploma or equivalent
- 2-3 years of supervisor experience required
- General knowledge of KPI development
- Prior plant production scheduling would be a plus.
- Prior team building, coaching, mentoring and performance development experience required
- Able to use Lean Production best practices (5S, Waste reduction, etc.) to drive continuous improvement.
- Experience with production/manufacturing in area of responsibility
- Knowledge of SOP’s and processes with Computer skills including Microsoft
Physical Requirements
- Regularly required to stand, walk and move throughout the facility for extended periods.
- Use of hands and arms to operate computers, review documents and interact with production equipment controls.
- Ability to see, hear, and communicate effectively to monitor production activities, provide instructions and ensure safety compliance.
- Occasional bending, stooping, kneeling or reaching to observe equipment, review workstations or participate in process improvement activities.
Job Type
- Full Time, Exempt
Wage
$90,000 - $100,000 annually
Benefits
- Health Insurance with Health Savings Account (if eligible)
- Dental/Vision Insurance
- Life/Disability Insurance
- 401(k) with employer match
- Paid Vacation/Sick Time
- Paid Holidays
- Employee Assistance Program
- Wellness Program
EQUAL OPPORTUNITY EMPLOYER
***THIS JOB IS ONSITE IN TAYLOR, TX***
-CANDIDATES WILLING TO RELOCATE ARE WELCOME-
Classification Levels
Mechanical Project Coordinator II 4-6yrs experience
Mechanical Project Coordinator III 7-10yrs experience
Mechanical Project Coordinator IIII 10+yrs experience
Job Description
MRI Inc. is seeking a Mechanical Project Coordinator II, III & IIII who will be in charge of managing administrative and organizational duties and acting as a point of contact between SAS and on-site contractors to ensure the project operates smoothly. Preferably, PCs should possess expertise in the specific areas they are assigned to oversee, to ensure effectiveness and clarity.
In this role you will:
- Bridge the gap between field operations and SAS Management.
- Minor administrative duties as defined by SAS.
- Develop and maintain a project communication plan.
- Coordinating meetings, including scheduling, sending invitations, and preparing agendas to maintain alignment between SAS and Contractors.
- Managing field-level project documentation, ensuring all forms and reports are accurately executed, correctly filed, and accessible.
- Promoting and maintaining a team atmosphere between SAS, coordinators, tool engineers, project managers, contractors, and vendors.
- Ensure timely progress reporting, providing stakeholders with accurate project status updates.
- Overseeing and managing the day-to-day field-level operational tasks and conflict resolution.
- Promptly taking ownership of delegated or observed issues and escalating them to the relevant Stakeholders.
- Monitor and maintain Daily Reporting (DR), Pre-Task Plans (PTPs), Site Risk Analysis (SRAs), and other relevant documentation ensuring both timely and accurate execution.
- Resolve field-level SOR quantity survey disputes, if required.
- Maintaining stop-work authority by investigating and stopping work when unsafe conditions are identified.
- Conduct spot compliance audits as directed by SAS.
- Incident documentation and investigation.
- Document and engage with SAS for lessons learned.
Requirements
- Journeyman license is preferred, but relevant certifications may be accepted at SAS’ discretion.
- Experience with semiconductor or related construction industries is preferred, but knowledge of applicable construction codes and installation best practices for MEP trades is mandatory.
- Bachelor's degree in construction management, engineering, or a related field experience is preferred.
- Minimum of 4+ years of experience in construction project coordination or management, must be knowledgeable and up to date with applicable construction codes regarding installation ‘best practices’ for MEP trades.
- Proven track record of successful projects completed.
- Similar project experience in Semiconductor, Advanced Technology, or Industrial projects.
- Excellent communication and organization skills.
- Journeyman level in Piping/Mechanical preferred
- Proficient in Microsoft Office Suite and related construction management software.
Validation Engineer
Contract: 6+ month duration with potential for extensions
Location: Woodstock, IL - ONSITE
Shift: First-shift hours; flexibility to support project timelines required
Industry: Sterile Liquids Manufacturing
Automated Systems, Inc. is seeking a highly capable Validation Engineer to support validation activities for Blow-Fill-Seal (BFS) equipment, with additional scope across compounding and packaging systems.
You will be working within a dynamic CDMO environment specializing in ophthalmic, inhalation, and irrigation products, helping to ensure all systems meet current Good Manufacturing Practices (cGMP), FDA, and client quality expectations.
Key Responsibilities:
- Lead and execute validation lifecycle documentation (URS, IQ, OQ, PQ) for Blow-Fill-Seal equipment used in sterile liquid product manufacturing.
- Support validation of compounding systems, including mixers, tanks, and associated CIP/SIP systems.
- Perform packaging line validation for sterile fill finish operations.
- Collaborate with cross-functional teams (QA, Engineering, Operations) to execute validation deliverables according to project timelines.
- Write and manage change controls, deviations, and CAPAs related to validation activities.
- Ensure all validation work aligns with internal SOPs, regulatory expectations, and customer-specific requirements.
- Assist in audit readiness activities and represent the validation function during inspections or client visits.
- Contribute to continuous improvement initiatives by identifying gaps and optimizing validation practices.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related technical field.
- Minimum 4 years of experience in pharmaceutical or medical device manufacturing.
- 4+ years of direct validation experience, including hands-on protocol generation and execution.
Preferred Qualifications:
- Strong understanding of BFS technology, sterile processes, and related regulatory standards (21 CFR Part 11, EU Annex 1, etc.).
- Experience in CDMO environments and third-party client interactions is preferred.
- Familiarity with ASTM E2500, GAMP 5, and risk-based validation approaches.
Immediate need for a talented Scientist I. This is a 12+ Months contract opportunity with long-term potential and is located in Waltham, MA, USA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job Diva ID: 26-08545
Pay Range: $ 46-$56 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
- Lead and conduct viral/non-viral vector purification process development and process analytics
- Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
- Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
- Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
- Perform troubleshooting experiments and communicate findings with appropriate working groups
- Maintain industry knowledge and keep abreast of new and relevant technologies
- Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
- Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
- Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
- Mentor and support junior staff and build a culture of support and collaboration
Key Requirements and Technology Experience:
- Key skills: - Purification experience/ Protein Purification Chromatography
- Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, - Late-stage purification experience such as design space mapping and process robustness studies
- PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master’s degree with a minimum of 4 years of relevant experience or a bachelor’s degree with a minimum of 6 years of relevant experience
- Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
- Significant experience, knowledge and understanding of purification technologies and operations such as:
- Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
- Protein purification chromatography
- Virus clearance and inactivation
- Familiarity with advanced purification technologies and process analytical technologies
- Familiarity with analytical method transfer, analytical method bridging across organizations
- Experience with process technology transfers and performing gap analyses and risk assessments
- Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
- Expertise in technical report writing
- Experience in AAV and/or non-viral purification development
- Experience in writing CMC components of regulatory dossiers
- Knowledge of product comparability, target product profile and quality risk assessment activities
- Viral clearance study design and execution
- Late-stage purification experience such as design space mapping and process robustness studies
- Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
- Ability to work under minimal supervision and function within a collaborative, team-oriented environment
- Excellent organization and communication skills
- Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
- Experience with biophysical characterization
- Experience in continuous manufacturing and process analytical technology
- Experience in mentoring junior staff
- Ability to build and nurture cross-functional relationships
- Ability to communicate and represent group in diverse, multi-functional meetings
Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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