Manufacturing Associate I, Upstream Processing (2nd shift)

System One; Pennington (NJ); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Job summary

System One is seeking a Manufacturing Associate I, Upstream Processing (2nd Shift) in Pennington, NJ. You will execute day-to-day upstream manufacturing operations in a CGMP cleanroom, handling media and buffer preparation, seed train expansion, bioreactor support, harvest processing, and aseptic processing to ensure GMP compliance.

The role requires basic biology manufacturing knowledge, strong attention to detail, good documentation, teamwork, and the ability to stand for long periods, lift up

Qualifications

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related field with 0–2 years of relevant experience.
• High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.

Responsibilities

• Upstream Manufacturing Operations.
• Prepare media and buffers according to approved procedures and batch records.
• Perform vial thaw, shake flask culture, seed train expansion, and bioreactor support activities.
• Support fed-batch and perfusion bioreactor operations.
• Execute harvest and filtration activities.
• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.
• Aseptic processing in classified cleanroom environments.
• Adhere to aseptic techniques and contamination control procedures.
• Follow gowning and cleanroom behavior requirements.
• Complete batch records, logbooks, and GMP documentation accurately and contemporaneously.
• Follow SOPs, batch records, and work instructions.
• Report deviations, equipment issues, and atypical events to supervision.
• Support internal audits and inspection readiness activities.
• Participate in training programs and qualification activities.
• Support process improvement initiatives and operational excellence projects.

Skills

Biological manufacturing knowledge

Cell culture operations

Documentation practices

Teamwork and communication

cGMP awareness

Physical stamina and PPE handling

Education

Bachelor's degree in Biotechnology or Life Sciences

High School Diploma with 4+ years biopharmaceutical experience

Tools

Bioreactor systems

Shake flask cultivation

Single-use technologies

Buffer and media preparation

Job description

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 Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and Biosimilar Developer

Position Overview

The Upstream Manufacturing Associate I is responsible for executing day-to-day upstream manufacturing operations in a cGMP cleanroom environment. This position supports cell culture manufacturing activities including media and buffer preparation, seed train expansion, bioreactor operations, harvest processing, equipment cleaning, and aseptic processing while ensuring compliance with GMP requirements.

Must Haves

• Basic understanding/experience in biological manufacturing and cell culture processes.
• Ability to follow detailed instructions and procedures.
• Strong attention to detail and documentation practices.
• Effective communication and teamwork skills.
• Knowledge of cGMP requirements is preferred.
• Ability to stand for extended periods.
• Ability to bend, reach, and lift up to 25 pounds.
• Ability to work in cleanroom environments while wearing required PPE.
• Experience with:
• Cell culture operations
• Shake flask cultivation
• Bioreactor systems
• Buffer and media preparation
• Single-use technologies
• Aseptic processing
• Education & Experience
• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience.
• or High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.

Key Responsibilities

• Upstream Manufacturing Operations
• Prepare media and buffers according to approved procedures and batch records.
• Perform vial thaw, shake flask culture, seed train expansion, and bioreactor support activities.
• Support fed-batch and perfusion bioreactor operations.
• Execute harvest and filtration activities.
• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.
• Aseptic Processing
• Perform manufacturing activities within classified cleanroom environments.
• Adhere to aseptic techniques and contamination control procedures.
• Follow gowning and cleanroom behavior requirements.
• Documentation & Compliance
• Complete batch records, logbooks, and associated GMP documentation accurately and contemporaneously.
• Follow SOPs, batch records, and work instructions.
• Report deviations, equipment issues, and atypical events to supervision.
• Support internal audits and inspection readiness activities.
• Continuous Improvement
• Participate in training programs and qualification activities.
• Support process improvement initiatives and operational excellence projects

System One, and its subsidiaries including Joulé and 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.