Engineering Jobs in Park City Illinois
23 positions found
Title - Process Technician
Location – Libertyville, Illinois
Experience – 4 years
Salary – as per the market standard
Job Description:
Mandatory Requirements:
• 3+ years of experience in injection molding or mold setup.
• Experience with hydraulic and electric injection molding machines.
• Certifications (Preferred):
• RJG Master Molder I or II
• Forklift Certification
• Education: High School Diploma or GED required.
• Associate’s degree in Plastics Technology, Manufacturing, or related field preferred.
Key Responsibilities:
• Machine Setup & Operation
• Set up molds, machines, and auxiliary equipment for production runs.
• Adjust machine parameters to maintain part quality and meet specifications.
• Start up and shut down molding machines per standard operating procedures.
• Troubleshooting & Maintenance
• Diagnose and resolve molding issues such as flash, short shots, or warping.
• Perform routine maintenance and minor repairs on molds and machines.
• Collaborate with maintenance and engineering teams for complex repairs.
• Quality Assurance
• Inspect molded parts for defects and ensure compliance with quality standards.
• Maintain documentation for process control, lot traceability, and corrective actions.
• Support root cause analysis and implement corrective actions for quality issues.
• Process Optimization
• Monitor mold performance and suggest improvements to reduce cycle time and scrap.
• Participate in continuous improvement initiatives and lean manufacturing efforts.
• Safety & Compliance
• Follow all safety protocols and ensure equipment is operated safely.
• Comply with ISO-13485, FDA CFR/GMP, and other regulatory requirements.
Position: Senior Project Manager – Pharma Manufacturing Tech Transfer
Duration: 12-36 months
Location: Remote with occasional onsite in 60087 - Waukegan
I am looking for a hands-on Sr Project Manager (8–12 years experience) to lead tech transfer and manufacturing rollout initiatives in a regulated pharma environment.
Business-side Orchestration
- Manufacturing Operations
- Process Development
- Digital and technology
This is NOT an IT or ERP role — it’s focused on manufacturing execution, validation, and site readiness.
This is a hands-on, execution-focused manufacturing PM role. You will manage projects and coordinate across plant-facing and cross functional teams.
Overview of Responsibilities
- Lead tech transfer from development into manufacturing
- Manage multi-site rollout and validation activities
- Drive integrated timelines across Manufacturing, QA, Engineering, and Ops
- Own risk tracking, milestones, and execution
- Support commercial launch and operational readiness
QUALIFICATIONS
- PMP or equivalent certification is prefered
- Bachelor of Science degree in chemistry, manufacturing, pharma, mechanical or electrical or engineering
- Pharma or cGMP manufacturing background
- Experience with tech transfer, validation, or product rollout
- Strong cross-functional leadership (plant + QA + engineering)
- Ability to bring structure to complex, fast-moving programs
- Engineering or scientific degree preferred
About us…Sterling Engineering, in business for 56 years …we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you receive a Full Employee Benefits Package that includes Paid Time Off, Paid Holidays, 3 Medical plans to choose from, Dental & Vision plans, 401(k) with a match, and an Employee Stock Ownership (ESOP) plan.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Our client is looking Automation Technician for Long Term project in Libertyville, Illinois (Onsite) Below is the detail requirement.
Title - Automation Technician
Location – Libertyville, Illinois
Experience – 5 years
Skills: PLCs, HMIs, servo motors, motion control systems, VFDs, and pneumatic/hydraulic equipment. Molding
Job Description:
Mandatory Requirement:
- 4 years of experience in injection moulding automation or related field.
- Hands-on experience with robot programming and troubleshooting.
Skills:
- Strong understanding of PLCs, HMIs, and industrial sensors.
- Ability to read electrical and mechanical schematics.
- Familiarity with EOAT (End-of-Arm Tooling) design and maintenance.
- Excellent problem-solving and communication skills.
- High School Diploma or GED required.
- Technical certification or associate’s degree in Mechatronics, Robotics, or Industrial Automation preferred.
Automation Troubleshooting
- Diagnose and resolve issues with molding automation systems, including robots, conveyors, sensors, and vision systems.
- Respond to alarms and faults in real-time to minimize downtime.
- Collaborate with engineering and maintenance teams to address recurring issues.
- Robot Programming & Optimization
- Program and fine-tune moulding robots (e.g., Sepro, Fanuc, Yushin, Wittmann) for part handling, degating, and packaging.
- Modify robot paths and sequences to improve cycle time and part quality.
- Maintain backups and documentation of robot programs and settings.
- Preventive & Corrective Maintenance
- Perform scheduled maintenance on automation equipment to ensure reliability.
- Replace worn components and calibrate sensors and actuators.
- Maintain detailed logs of maintenance activities and equipment performance.
- Process Support & Continuous Improvement
- Support Mold trials and new product launches by setting up automation sequences.
- Recommend and implement improvements to automation layouts and workflows.
- Participate in kaizen events and lean manufacturing initiatives.
- Safety & Compliance
- Ensure all automation systems operate within safety guidelines.
- Maintain compliance with ISO, FDA, and GMP standards where applicable.
Akkodis is seeking a Senior Mechanical Engineer for a 3+ Contract position with a client located in Waukegan, IL
Pay Range: $50/hr - $60/hr (The rate may vary based on experience, education, geographic location, and other factors.)
Position Responsibilities
We are seeking a highly skilled Senior Mechanical Engineer with strong experience designing mechanical solutions for electrical and electromechanical systems. This role focuses on sheet metal design, electrical component placement, enclosure design, and wire harness routing, with an emphasis on delivering robust, manufacturable designs that integrate seamlessly with electrical system requirements.
Key Responsibilities
- Lead mechanical design efforts for electromechanical products including enclosures, chassis, brackets, and system-level packaging.
- Create detailed 3D models and engineering drawings using CREO or SolidWorks, including GD&T, BOMs, and tolerance stack-ups.
- Develop sheet metal designs that meet structural, thermal, manufacturability, and cost requirements.
- Plan and execute electrical component placement, mechanical packaging, and integration with PCBs, power supplies, connectors, and cable assemblies.
- Design and route wire harnesses and cable assemblies to ensure proper fit, bend radius, and strain relief.
- Partner closely with Electrical Engineers to ensure design compatibility, grounding, shielding, and component accessibility.
- Work with Manufacturing Engineering to optimize designs for fabrication processes such as sheet metal forming, machining, injection molding, and assembly.
- Collaborate with Application Engineering to incorporate customer requirements and field-use conditions.
- Perform thermal, structural, and airflow considerations in mechanical layouts.
- Support prototype builds, testing, validation, and design revisions.
- Participate in design reviews, risk assessments, DFMEA, and continuous improvement initiatives.
- Maintain engineering documentation, revision control, and compliance with internal standards.
Required Skills
- Bachelor's degree in mechanical engineering or related field.
- 6+ years of mechanical design experience in an electromechanical or electronics-packaging environment.
- Proficiency in CREO or SolidWorks (assembly modeling, surfacing, sheet metal, drawings).
- Experience with sheet metal enclosure design, component packaging, and mechanical layout for electrical systems.
- Experience with wire harness layout/design and cable management.
- Strong understanding of manufacturing processes, DFM/DFA, and design best practices.
- Experience with thermal management, airflow design, or electronics cooling.
- Familiarity with regulatory and safety standards (UL, IEC, CE, etc.).
- Knowledge of vibration and shock testing for critical infrastructure products.
If you are interested in this Senior Mechanical Engineer job, then please click APPLY NOW. For other opportunities available at Akkodis go to If you have questions about the position, please contact Sunny Kumar at .
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit Company will consider qualified applicants with arrest and conviction records by federal, state, and local laws and/or security clearance requirements, including, as applicable:
· The California Fair Chance Act
· Los Angeles City Fair Chance Ordinance
· Los Angeles County Fair Chance Ordinance for Employers
· San Francisco Fair Chance Ordinance
Key Responsibilities:
- Prepare project cost codes and review accounting reports to ensure accuracy.
- Track project costs weekly and provide regular financial updates and profit projections.
- Assist with monthly pay applications and coordinate billing schedules.
- Review and approve subcontractor and supplier payments based on completed work and contract terms.
- Maintain project draw projections and schedules of values.
- Distribute construction drawings, addenda, and change bulletins to subcontractors.
- Maintain project documentation including drawing logs, change order logs, submittal logs, and RFIs.
- Manage project management software and ensure all documentation is current and organized.
- Coordinate and process submittals and RFIs in a timely manner.
- Develop and maintain accurate project schedules and provide updates during project meetings.
- Lead weekly job meetings and distribute meeting minutes.
- Coordinate communication between the owner, architect, city officials, subcontractors, and consultants.
- Track project progress and labor in coordination with the superintendent.
- Issue and manage change orders and track project impacts.
- Coordinate pre-punch and final punch list activities with the superintendent and subcontractors.
- Prepare project closeout documentation, including O&M manuals.
- Coordinate final inspections and obtain the Certificate of Occupancy.
Qualifications:
- 5+ years of construction project management experience (preconstruction and estimating experience preferred).
- Experience with civil and structural construction strongly preferred.
- Bachelor’s degree in Construction Management, Civil Engineering, or a related field preferred.
- Strong proficiency with Microsoft Office (Excel, Word, Outlook).
- Experience with estimating, scheduling, and quantity take-off software.
- Excellent organizational, communication, and problem-solving skills.
- Strong attention to detail and ability to manage multiple priorities.
Location: Mettawa, IL
Work Model: Hybrid – onsite approximately one week per month
Contract Duration: Through December 2026 (extension likely)
Rate: $21-26/HR based on benefit selection
Orion Group's pharmaceutical client is seeking an Operations Support III professional to join the U.S. Patient Services (APS) Operations team. The APS organization is recognized as an industry leader in delivering high-quality patient support programs that enhance both patient satisfaction and brand loyalty.
This role provides operational coordination, reporting, and project support to ensure efficient service delivery across APS initiatives. The position reports to the Director or Associate Director of APS Operations and collaborates closely with internal teams and external vendors.
Key Responsibilities
Operational Coordination
- Coordinate onboarding and offboarding processes in partnership with internal stakeholders and external vendors
- Support operational workflows to ensure continuity and efficiency of APS programs
- Identify and recommend process improvements and operational efficiencies within APS operations
- Support initiatives that enhance workflow consistency and service delivery quality
- Monitor and manage tickets within a custom issue management system
- Analyze trends, identify recurring issues, and support resolution efforts
- Provide project management and operational support across APS initiatives
- Develop and maintain routine reports using Microsoft Excel
- Create PowerPoint presentations for leadership and stakeholder updates
- Assist with special projects and ad hoc operational initiatives as assigned by APS Operations leadership
- Strong written and verbal communication skills
- High level of attention to detail and accuracy
- Ability to manage multiple priorities in a fast-paced environment
- Strong organizational and time management skills
- Comfortable working across multiple systems and tools simultaneously
- Proficiency in Microsoft Office, particularly Excel and PowerPoint
The ideal candidate is a highly organized operations professional who thrives in collaborative environments and enjoys supporting operational processes, reporting, and cross-functional initiatives.
Experience supporting healthcare, pharmaceutical, patient services, or operational teams is a plus.
People are our business worldwide
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.
The Construction Superintendent takes part in leading a team of dedicated Foreman and Laborers through the entire project life-cycle. As the Construction Superintendent, you will be involved in pre-construction planning through final completion by planning, directing, and participating in the field operations to ensure projects are completed to company and client standards.
ESSENTIAL DUTIES AND RESPONSIBILTIES:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties and responsibilities.
- Adhere to and uphold all Company safety practices, procedures and policies.
- Direct team activities, establishing task priorities, labor hour management, scheduling and tracking work assignments, providing guidance, and ensuring the availability of resources.
- Assist in coordination of landscape construction activities to meet or exceed both project and company profitability goals.
- Motivate and supervise multiple diversified crews on a daily basis.
- Responsible to drive daily in a company vehicle with or without passengers.
- Working knowledge of Aspire.
- Responsible for submitting accurate and timely paperwork, time records, work orders, reports, and other documents that are required.
- Inspect onsite work activities of company and subcontractor crews to ensure work is being performed correctly and to company standards.
- Correspond with clients, salespersons, construction manager, project manager, foreman, purchasing team, etc. on material status and production planning with a professional working relationship.
- Ability to communicate with customers to ensure constant customer satisfaction.
- Plan for and procure special equipment as needed on a site-by-site basis.
- Review and approve time records, work orders, and change orders in coordination with appropriate departments.
- Assist in the recruiting and selecting of qualified candidates for Foreman, Driver, and Laborer positions. Consider performance appraisals for Foreman, Driver, and Laborer positions in conjunction with construction manager and human resources department.
- Coordinate with Director of Construction Operations and Safety Manager to achieve safety goals by training employees and promoting a safe and positive work environment at all times.
- Create, implement and track rewards programs for construction field employees, if applicable.
- Be willing to work physically alongside Foreman and Laborers as needed.
- Utilize appropriate technologies to facilitate information management and record keeping.
- Communicate and resolve needs, issues, safety concerns and/or problems to supervisor in a timely manner.
- Develop and maintain good communication, high safety standards, and positive relations with coworkers, clients and the public.
- Represent the Company in a positive manner befitting our brand and image.
- Perform other duties as assigned.
SUPERVISORY RESPONSIBILITIES:
- Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include safety, planning, assigning, and directing work, addressing complaints and resolving problems.
QUALIFICATIONS:
- Five years or more of related experience and/or training; or equivalent combination of education and experience.
- Knowledge of construction building techniques, including but not limited to: hardscapes, irrigation, fencing, bluff development, grading, drainage, planting, lighting, and boulder work. Must have the ability to read and interpret; engineering, structural, grading, drainage, landscape and general construction drawings. General knowledge of village codes and permitting.
- Must demonstrate knowledge of the safety issues, regulations, and procedures utilized in public and private works activities.
- Experience in Aspire is preferred.
- Candidates must have a valid local driver’s license and maintain a good driving record
- Required to pass a post-offer DOT medical physical and drug screen, and (ongoing) periodic DOT physical and drug screen according to DOT guidelines.
- Ability to lift 75 pounds, repetitively and frequently, and perform physical field work.
- Must be 21 years or older.
- Qualified candidates must be legally authorized to work in the United States.
- Ability to effectively present information and respond to questions from clients, managers, co-workers and the general public.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Must be able to communicate in English, including: read, write, and with use of computers and phones.
PERFORMANCE OF DUTIES:
- Employee shall also perform other incidental and related duties as required and assigned or implied from the foregoing, consistent with the background, training and qualifications of Employee or may be reasonably delegated as being in the best interests of the Company.
- The Employee shall devote full time to their employment and expend best efforts on behalf of Company.
- Employee further agrees to abide by all Company policies and decisions now or hereinafter existing.
AMERICANS WITH DISABILITY SPECIFICATIONS:
Physical Demands
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, twist, crouch or crawl; talk or hear; taste or smell.
- Work requires some physical exertion such as long periods of standing: walking over rough, uneven surfaces; and recurring bending, crouching, stooping and reaching; and frequent lifting of moderately heavy items.
- The employee must occasionally lift and/or move up to 75 pounds. Work requires average physical agility and dexterity.
- Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work Environment
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is exposed to weather conditions prevalent at the time.
- Work is performed primarily out-of-doors involving moderate risks, discomfort, or unpleasantness such as a moderate level of noise; dust, grease or mud; moving vehicles or machines; cold, hot and/or wet weather.
- Normal safety precautions are required; and the incumbent may wear some protective clothing and equipment such as rain and snow gear, boots, protective eyewear and gloves.
- The noise level in the work environment is usually moderate.
Work Location: North Chicago, IL 60064
Assignment Duration: 06 Months (Possible Extension)
Work Arrangement: Onsite
Position Summary: The Laboratory Coordinator will develop and administer various laboratory equipment support functions throughout our organization's R&D sites. This position involves serving as liaison among our organization's internal personnel as well as external organizations, to aid in equipment selection, purchasing (equipment and services), onboarding, calibration/service/repair, and decommissioning.
Background & Context: These functions will be executed with consideration for laboratory needs, as well as quality and cost effectiveness of internal and external service providers.
Key Responsibilities:
- Interface with vendors, OEM, and internal service organizations to address laboratory equipment service needs.
- Assist R&D personnel with selection and purchase of laboratory equipment and services.
- Provide administrative support throughout equipment lifecycle (onboarding, maintenance/repair, decommissioning).
- Serve as liaison to on-site vendor service personnel.
- Receive incoming work requests and generate workorders on demand.
- Process work orders and contracts within IBM Maximo system to ensure equipment status, service activities, and all cost of ownership expenses are properly documented.
- Maintain equipment warranty and service contract data within Maximo system and Access database.
- Process service contract renewals, including review of equipment reliability histories, determination of insourcing potential, and overall assessment of cost benefits.
- Work with department leadership to develop and refine processes in support of department functions.
Qualifications & Experience:
- College Degree or equivalent experience. A technical degree (Engineering or Science) is preferred.
- Knowledge of basic regulatory requirements, laboratory safety, and GxP.
- At least 2+ years of experience with a variety of laboratory equipment, either having served as a lab analyst, lab equipment service provider, or both.
- Effective written and oral communication skills capable of accommodating a diverse audience.
- Proficient in data entry, analysis, and presentation, particularly within Maximo, Cognos, and SAP environments.
- Attention to detail, strong organization and planning skills.
- Capable of independently developing creative solutions in a fast-paced environment.
- Self-motivated and positive attitude with a great desire to contribute to our success.
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.
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.