Manufacturing Associate III, Downstream Processing (3rd shift)
Pennnington, New Jersey
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Onsite
Brand: System One
Job ID: 382326
Date Posted: 10/30/2026
Shortcut: http://jobs.systemone.com/u17dn2
Job Title: Manufacturing Associate III, Downstream Processing (3rd shift)
Location: Pennnington, New Jersey
Type: Contract To Hire
Work Model: Onsite- Monday-Friday 10pm-6am
Pay Rate: $33-00-$37.50hr (Based on experience)
plus $3 differential for 3rd shift
Responsibilities
- Lead daily downstream manufacturing operations and provide shop-floor technical support.
- Coordinate execution of manufacturing campaigns and purification schedules.
- Ensure manufacturing readiness, equipment availability, and material preparedness for batch execution.
- Serve as the primary technical resource during downstream manufacturing operations.
- Provide real-time decision support during process execution and batch recovery activities.
- Lead all purification operations including Protein A capture, viral inactivation, ion exchange chromatography, UF/DF, viral filtration, and final bulk drug substance processing.
- Oversee operation and performance of chromatography skids, AKTA systems, BioSC, TFF systems, and filtration equipment.
- Monitor critical process parameters and ensure adherence to process specifications.
- Troubleshoot process and equipment issues to maintain operational continuity.
- Support implementation of process improvements and manufacturing optimization efforts.
- Lead preparation and revision of:
- Standard Operating Procedures (SOPs)
- Master Batch Records (MBRs)
- Manufacturing Forms and Logbooks
- Equipment and Process Documentation
- Support deviation investigations, CAPAs, change controls, and risk assessments.
- Ensure continuous inspection readiness and GMP compliance.
- Participate directly in regulatory inspections and client audits.
- Support review and approval of manufacturing documentation for batch release readiness.
- Coordinate activities between Manufacturing, QA, QC, MSAT, Validation, Engineering, Facilities, Warehouse, and Supply Chain teams.
- Support technology transfer projects from process development through GMP manufacturing.
- Participate in process validation, PPQ campaigns, and commercial manufacturing programs.
- Lead manufacturing readiness reviews and campaign planning meetings.
- Drive continuous improvement and operational excellence initiatives.
- Train, mentor, and develop Associate I and Associate II personnel.
- Provide technical coaching and floor-based leadership.
- Support qualification programs and onboarding activities.
- Assist supervisors with scheduling, work assignments, and personnel development plans.
Requirements
- Advanced expertise in downstream purification operations and biologics manufacturing.
- Extensive experience with Protein A and polishing chromatography processes.
- Strong hands-on experience operating AKTA chromatography systems and TFF platforms.
- Advanced knowledge of viral filtration, UF/DF, and sterile filtration processes.
- Strong understanding of GMP regulations, manufacturing systems, and documentation requirements.
- Proven leadership, decision-making, and organizational skills.
- Excellent troubleshooting and problem-solving capabilities.
- Ability to effectively coordinate cross-functional manufacturing activities.
- Ability to stand for extended periods.
- Ability to bend, reach, and lift up to 50 pounds.
- Ability to work in cleanroom environments while wearing required PPE.
- Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience.
- Previous lead operator, project coordination, or team leadership experience preferred.
- Experience supporting late-stage clinical or commercial biologics manufacturing preferred.
- Preferred Skills Technology Transfers
- Process Validation and PPQ Campaigns
- Commercial Manufacturing Operations
- Regulatory Inspections and Client Audits
- CAPA and Deviation Management
- Continuous Improvement and Lean Manufacturing Initiatives
System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
#LI-
Ref: #558-Scientific
-
Manufacturing Associate I, Downstream Processing (3rd shift)
Pennnington, New Jersey
Job Title: Manufacturing Associate I, Downstream Processing (3rd shift) Location: Pennington, New Jersey Type: Contract To Hire Compensation: $22.00/hr to $25.00/hr +3 dollar shift differential Work Model: Onsite – onsite Hours: 40.0 hours per week Pos...
Date Posted: 10/28/2026 Recommended
-
Manufacturing Associate I, Downstream Processing (2nd shift)
Pennnington, New Jersey
Job Title: Manufacturing Associate I, Downstream Processing (2nd shift) Location: Pennington, NJ Type: Contract To Hire Compensation: $22.00/hr to $25.00/hr +2 dollar shift differential Work Model: Onsite – onsite Hours: 40.0 Position Overview The Down...
Date Posted: 10/28/2026 Recommended
-
Lead Mechanic
Dayton , NJ
Job Title: Lead Mechanic Location: Dayton, NJ Type: Direct Hire Compensation: Up to $40 per hour- based on experience Contractor Work Model: Onsite Hours: 7 AM- 3:30 PM Responsibilities Oversee and support the maintenance, troubleshooting, and optimiza...
Date Posted: 08/06/2026 Recommended
-
Product Support Engineer
Oxford, Georgia
Job Title: Product Support Engineer Location: Oxford, Georgia Type: Direct Hire Work Model: Onsite-Travel Required Product Support Engineer Position Summary The Product Support Engineer provides hands-on technical support to sales and operations teams ...
Date Posted: 10/23/2026 Recommended
-
Pre- Weigher
Wharton, NJ
Job Title: Pre-Weigher Location: Wharton, NJ Type: Direct Hire Pay: $20 per hour Hours: 1st Shift: 7:00 AM - 3:00 PM or 2nd Shift: 3:00 PM - 11:00 PM or 3rd Shift: 11:00 PM - 7:00 AM Responsibilities: Accurately weigh, dispense, label, and stage raw ma...
Date Posted: 10/22/2026 Recommended
-
Line Mechanic
Wharton, NJ
Job Title: Line Mechanic Location: Wharton, NJ Type: Direct-Hire Compensation: $27.00–$30.00/hour Work Model: Onsite Hours: 1st Shift: 7:00 AM–3:00 PM 2nd Shift: 3:00 PM–11:00 PM 3rd Shift: 11:00 PM–7:00 AM Summary The role supports manufacturing and f...
Date Posted: 10/22/2026 Recommended
-
Quality Manager (Filling Operations)
Ledgewood, NJ
Job Title: Quality Manager (Filling Operations) Location: Ledgewood, NJ Type: Direct Hire Compensation: $85,000 - $105,000 Hours: 6:30 AM - 3:00 PM, Monday - Friday Responsibilities Lead and oversee all quality activities within filling operations for ...
Date Posted: 10/22/2026 Recommended
-
Manufacturing Team Lead
Ruther Glen, VA
Manufacturing Team Lead Location: Ruther Glen, VA Schedule: 2nd Shift Monday–Thursday, 5:00 PM–3:00 AM (4x10s) + potential overtime Pay: $29 - $35 per hour Type: Direct Hire Role Summary Hands-on production lead role supporting daily manufacturing/asse...
Date Posted: 10/08/2026 Recommended
-
Manufacturing Associate I, Upstream Processing (2nd shift)
Pennnington, New Jersey
Job Title: Manufacturing Associate I, Upstream Processing (2nd Shift) Location: Pennington, New Jersey Shift: 2:00 PM - 10:00 PM, Monday-Friday Pay: $22.00 - $25.00/hour (Based on Experience), Plus $2 Shift differential Industry: Global Biopharmaceutic...
Date Posted: 10/22/2026 Recommended
-
Manufacturing Associate II, Upstream Processing (3rd shift)
Pennnington, New Jersey
Job Title: Manufacturing Associate II, Upstream Operations (3rd Shift) Location: Pennington, NJ Shift: 3rd Shift, 10pm-6am M-F Pay: $26.00-$32.00/hr + $3.00/hr Shift Differential Industry: Global Biopharmaceutical Contract Development and Manufacturing...
Date Posted: 10/28/2026 Recommended
-
Manufacturing Engineering Manager
Manheim, PA
Job Title: Manufacturing Engineering Manager Location: Manheim, PA Type: Direct Hire Work Model: Onsite Responsibilities Lead, coach, and develop manufacturing engineering, test engineering, and maintenance teams supporting electronic assembly, testing...
Date Posted: 10/23/2026 Recommended
-
Inventory & Production Manager
Baltimore, MD
Job Title: Purchasing & Production Associate Location: Baltimore, MD 21226 (onsite) Type: Direct Hire Duties and Responsibilities: Build and maintain good business vendor relationships while seeking out new or alternative vendors as required Maintainin...
Date Posted: 10/14/2026 Recommended
-
Manufacturing Associate II, Upstream Processing (2nd shift)
Pennnington, New Jersey
Job Title: Manufacturing Associate II, Upstream Operations 2nd shift Location: Pennington, NJ (Greater Hopewell NJ area) Shift: 2nd Shift 2pm-10pm M-F Salary (Pay) Range: $26.00/hour to $32.00/hour, plus $2 shift Differential for 2nd shift Industry: Gl...
Date Posted: 10/28/2026 Recommended
-
Plant Manager
Wellsburg, West Virginia
Job Title: Plant Manager Location: Wellsburg, WV Type: Direct Hire Compensation: $180,000.00- $190,000.00 Work Model: Onsite – onsite Responsibilities Own site safety performance: eliminate hazards, strengthen near-miss reporting, and ensure timely clo...
Date Posted: 09/02/2026 Recommended
-
Senior Process Engineer
Huntingdon, Pennsylvania
Job Title: Senior Process Engineer Location: Huntingdon, PA Type: Direct Hire Compensation: $110,000.00 - $140,000.00 Work Model: Onsite – onsite Hours: 40.0 Overview Drive process improvement and operational excellence in fiberglass and composite manu...
Date Posted: 08/10/2026 Recommended
-
Purification & Analytics Scientist
Boston, Massachusetts
Job Title: Purification & Analytics Scientist Location: Boston, MA Type: Contract to Hire Compensation: $84.13 Work Model: Onsite Hours: Standard business hours Security Clearance: Not specified Overview: Join a growing U.S. biotechnology organization ...
Date Posted: 10/12/2026 Recommended
-
Quality Engineer
Huntingdon, Pennsylvania
Job Title: Quality Engineer Location: Huntingdon, PA Type: Direct Hire Compensation: $110,000.00 - $140,000.00 Work Model: Onsite – onsite Hours: 40.0 Overview The Quality Engineer ensures manufacturing processes and products meet quality, safety, and ...
Date Posted: 08/18/2026 Recommended
-
Quality Engineer
Carson, CA
Job Title: Quality Engineer Location: Santa Fe Springs, CA Type: Direct Hire Compensation: $100,000.00 - $120,000.00 Work Model: Onsite Overview Quality Engineer is responsible for ensuring that rail vehicle equipment and components meet engineering sp...
Date Posted: 08/19/2026 Recommended
-
Production Operator
Orangeburg, NY
Job Title: Production Operator Location: Orangeburg, NY Type: Contract to hire Work Model: Onsite – onsite Hours: Monday-Friday; 1st shift: 7am-3:30pm or 2nd Shift: 2pm-10:30pm Responsibilities • Maintain all production areas in a clean and orderly man...
Date Posted: 10/23/2026 Recommended
-
Manufacturing Compounder
Wharton, NJ
Job Title: Manufacturing Compounder Location: Wharton, NJ Type: Direct Hire Pay: $25 hour/flex Hours: All Shifts Available Responsibilities: Weigh and dispense raw materials according to batch records and formulations Verify material identity, lot numb...
Date Posted: 10/22/2026 Recommended
-
Process Engineer
Manheim, PA
Job Title: Process Engineer Location: Manheim, PA Type: Full-time Work Model: Onsite Responsibilities • Develop, implement, and optimize manufacturing processes for assembly and production operations, including electrical/electronic assemblies, valves,...
Date Posted: 10/23/2026 Recommended
-
Manufacturing Associate I, Upstream Processing (3rd shift)
Pennnington, New Jersey
Job Title: Manufacturing Associate I, Upstream Processing (3rd Shift) Location: Pennington, NJ 08534 Shift: Monday-Friday, 10:00 PM - 6:00 AM Pay Rate: $22.00 - $25.00 per hour (Based on Experience), Shift Differential +$3/hour Industry: Global Biophar...
Date Posted: 10/28/2026 Recommended
-
Mortars Operator
Sealy, TX
Job Title: Mortars Operator Location: Sealy, TX Type: Contract To Hire Compensation: $19 / hr. Work Model: Onsite Hours: 2nd Shift Monday-Friday 3:00 PM - 11:30 PM Responsibilities: Follow all safety, security, and environmental policies and procedures...
Date Posted: 10/26/2026 Recommended
-
Assembly Technician
Chattanooga, TN
Job Title: Assembly Technician Location: Chattanooga, TN Type: Direct Hire Work Model: Onsite – onsite Must be available and flexible to work both day and night shifts as business needs require Shifts: Days- Monday- Friday 6:00am-2:30pm Nights- Monday-...
Date Posted: 10/02/2026 Recommended
-
Electro-Mechanical Assembler
Leetsdale, Pennsylvania
Job Title: Electromechanical Assembler Location: Leetsdale, PA Type: Direct Hire Compensation: $21.70/hr Work Model: Onsite – onsite Hours: 40.0; 1st, 2nd, 3rd Shifts Responsibilities Cross-trained to fill in for or support various hourly roles using g...
Date Posted: 08/26/2026 Recommended
-
Admix Operator
Sealy, TX
Job Title: Admix Operator Location: Sealy, TX Type: Contract To Hire Compensation: $19 / hr. Work Model: Onsite Hours: 2nd Shift Monday-Friday 3:00 PM - 11:30 PM Responsibilities: Follow all safety, security, and environmental policies. Execute product...
Date Posted: 10/26/2026 Recommended
-
Quality Technician
Santa Fe Springs, CA
Job Title: Quality Technician Location: Santa Fe Springs, CA Type: Full-time / Hourly (Non-Exempt) Compensation: $45,000.00 – $54,000.00 Work Model: Onsite Overview The Quality Technician is responsible for ensuring that all incoming materials, in-proc...
Date Posted: 08/20/2026 Recommended
-
Packaging Associate II - 3rd Shift
Macungie, PA
Job Title: Packaging Associate II - 3rd Shift Location: Macungie, PA 18062 Type: Contract To Hire Compensation: $19.00/hour + $2 shift differential Hours: 11:00PM-7:00AM, Sunday-Thursday Overview Established and growing pharmaceutical manufacturing com...
Date Posted: 09/16/2026 Recommended
-
Commissioning Director
Tempe, AZ
Job Title: Commissioning Director Location: Tempe, AZ Type: Full-time Compensation: $135,000.00 - $200,000.00 Work Model: Onsite Overview The Director of Commissioning leads and supports teams responsible for ensuring that building systems are designed...
Date Posted: 09/30/2026 Recommended
-
Inventory Assistant
Parlin, NJ
Job Title: Inventory & Parts Associate Location: Parlin, NJ Type: Temp-to-hire Compensation: $20 - $24 per hour (based on experience) Hours: Monday - Friday, 8:00 AM - 4:30 PM Inventory & Parts Associate Responsibilities: Preforms inventory cycle count...
Date Posted: 10/30/2026 Recommended
⚠️ Protecting Job Seekers from Identity Scams
At System One, your privacy and security are important to us. As job-related scams continue to target job seekers, we want to help you recognize and avoid common recruitment fraud. Identity theft scams often involve individuals, also known as "scammers," posing as recruiters or employers to obtain sensitive personal information, such as Social Security numbers, bank account details, or copies of driver’s licenses, with the goal of stealing identities, accessing financial accounts, or creating fraudulent accounts in a victim’s name.