Back to Jobs search

Manufacturing Associate III, Downstream Processing (3rd shift)

System One • Pennington, NJ • 50min ago

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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.

Similar Jobs

Warehouse Worker

Sysco • Sayreville, NJ • 36min ago

Manufacturing & Warehouse

Position Summary: The Warehouse Worker is responsible for the following warehouse activities including but not limited to: shipping, receiving, putaway, replenishment, item demand, consolidation, count checks, loading an...

36min ago

Go to Apply

Manufacturing Operator

Actalent • Cranbury, NJ • 1h ago

Manufacturing & Warehouse

Job Title: Manufacturing OperatorJob Description The Manufacturing Operator works under direct supervision to operate pharmaceutical manufacturing equipment in a cGMP environment to produce clinical supplies and support...

1h ago

Go to Apply

IMMEDIATE HIRING | Warehouse Worker | 5AM - 1.30 PM | $18.25/HR

Aerotek • Dayton, NJ • 1w ago

Manufacturing & Warehouse

Job Title: Warehouse Worker Job Description Join a dynamic warehouse team where you will handle a variety of shipping, receiving, stocking, and inventory tasks in a fast-paced environment. You will play a key role in kee...

1w ago

Go to Apply

IMMEDIATE HIRING | Warehouse Worker | 5 AM - 1.30 PM | $18.25/HR

Aerotek • Dayton, NJ • 1w ago

Manufacturing & Warehouse

1w ago

Go to Apply

IMMEDIATE HIRING | Warehouse Worker | 2 PM - 10.30 PM | $19.75/HR

Aerotek • Dayton, NJ • 1w ago

Manufacturing & Warehouse

1w ago

Go to Apply

Warehouse Team Lead

Primo Brands • Somerset, NJ • 1w ago

Manufacturing & Warehouse

Overview Primo Brands is a leading branded beverage company in North America with a focus on healthy hydration. We are proud to offer an extensive and iconic portfolio of highly recognizable, sustainably sourced, and con...

1w ago

Go to Apply

Manufacturing Associate I, Upstream Processing (3rd shift)

System One • New Jersey, New Jersey • 1w ago

Manufacturing & Warehouse

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 +...

1w ago

Go to Apply

Manufacturing Associate I, Downstream Processing (3rd shift)

System One • New Jersey, New Jersey • 1w ago

Manufacturing & Warehouse

Job Title: Manufacturing Associate I, Downstream Processing (3rd shift) Location: Pennnington, New Jersey Type: Contract To Hire Compensation: $22.00/hr to $25.00/hr Work Model: Onsite - onsite Hours: 40.0 hours per week...

1w ago

Go to Apply

Manufacturing Associate I, Downstream Processing (2nd shift)

System One • New Jersey, New Jersey • 1w ago

Manufacturing & Warehouse

Job Title: Manufacturing Associate I, Downstream Processing (2nd shift) Location: Pennnington, NJ Type: Contract To Hire Compensation: $22.00/hr to $25.00/hr Work Model: Onsite - onsite Hours: 40.0 Position Overview The...

1w ago

Go to Apply

Automotive Detailer - Car Washer - Elkins Park

Enterprise Mobility • Elkins Park, PA • 3w ago

Manufacturing & Warehouse

Overview Enterprise Mobility is seeking a responsible, dedicated person to join our team as a full time Automotive Detailer. The starting compensation for this job is $17 / hour based on a 40 hour workweek. Employees can...

3w ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)