Manufacturing Associate I, Downstream Processing (2nd shift)

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

Benefits offered by this job

Health benefits

Dental plan

Vision plan

Life insurance

401(k) plan

Job summary

System One is seeking a Manufacturing Associate I, Downstream Processing, on second shift, onsite in Pennnington, NJ. This contract-to-hire role supports downstream manufacturing in a cGMP cleanroom, performing buffer prep, chromatography, filtration, and aseptic processing under GMP guidelines.

You'll assist with equipment setup, cleaning, and process monitoring, while maintaining precise documentation and batch records.

Qualifications

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related discipline.
• 0-2 years of relevant experience.
• High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.
• Knowledge of cGMP requirements is preferred.
• Ability to follow detailed manufacturing procedures.

Responsibilities

• Support day-to-day downstream manufacturing operations in a cGMP cleanroom.
• Assist with purification and processing activities including buffer preparation, chromatography operations, filtration processes, equipment setup, cleaning, and aseptic manufacturing activities while maintaining compliance with GMP requirements.
• Prepare buffers and process solutions according to approved procedures and batch records.
• Support chromatography operations including column packing, column preparation, and system setup.
• Perform filtration operations including depth filtration, tangential flow filtration (TFF), and sterile filtration.
• Execute product pooling, sampling, and material transfers.
• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.
• Assist with chromatography processes and support UF/DF operations using TFF systems.
• Operate single-use flow paths and associated downstream equipment.
• Perform process monitoring activities under supervision.
• 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 and qualification programs.
• Support process improvement and operational excellence initiatives.
• Assist with manufacturing readiness activities.

Skills

Attention to detail

Documentation

Teamwork

Effective communication

cGMP awareness

Education

Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related discipline

High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience

Tools

AKTA chromatography platforms

Tangential Flow Filtration (TFF)

Single-use technologies

Chromatography systems

Buffer preparation

Sterile processing

Job description

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 Downstream Manufacturing Associate I is responsible for supporting day-to-day downstream manufacturing operations in a cGMP cleanroom environment. This position assists with purification and processing activities including buffer preparation, chromatography operations, filtration processes, equipment setup, cleaning, and aseptic manufacturing activities while maintaining compliance with GMP requirements.

Responsibilities

• Support day-to-day downstream manufacturing operations in a cGMP cleanroom environment.
• Assist with purification and processing activities including buffer preparation, chromatography operations, filtration processes, equipment setup, cleaning, and aseptic manufacturing activities while maintaining compliance with GMP requirements.
• Prepare buffers and process solutions according to approved procedures and batch records.
• Support chromatography operations including column packing, column preparation, and system setup.
• Perform filtration operations including depth filtration, tangential flow filtration (TFF), and sterile filtration.
• Execute product pooling, sampling, and material transfers.
• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.
• Assist with chromatography processes and support UF/DF operations using TFF systems.
• Operate single-use flow paths and associated downstream equipment.
• Perform process monitoring activities under supervision.
• 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 and qualification programs.
• Support process improvement and operational excellence initiatives.
• Assist with manufacturing readiness activities.

Requirements

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience.
• High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.
• Basic understanding of biologics purification and downstream processing.
• Ability to follow detailed manufacturing procedures.
• Strong attention to detail and documentation practices.
• Effective communication and teamwork skills.
• Knowledge of cGMP requirements is preferred.
• Experience with: Chromatography systems, Tangential Flow Filtration (TFF), Buffer preparation, AKTA chromatography platforms, Single-use technologies, Aseptic processing.
• Physical ability to stand for extended periods, bend, reach, and lift up to 25 pounds.
• Ability to work in cleanroom environments while wearing required PPE.

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.

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Ref: #558-Scientific