Manufacturing Associate I, Downstream Processing (3rd shift)

System One; Pennington (NJ); Presencial; USD 30 000 - 34 000; Tempo integral

Resumo da oferta

System One is hiring a Manufacturing Associate I for downstream processing in a cGMP cleanroom in Pennnington, NJ. This 3rd-shift, onsite role supports purification, buffer prep, chromatography, filtration, and aseptic activities with a focus on precise documentation.

Candidates may have a Bachelor's in a life sciences field or substantial related experience. The role emphasizes adherence to SOPs, batch records, and GMP compliance, with potential contract-to-hire outcomes.

Qualificações

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline.
• 0-2 years of relevant biopharmaceutical manufacturing experience.
• Basic understanding of biologics purification and downstream processing.
• Ability to follow detailed manufacturing procedures.
• Strong attention to detail and documentation practices.
• Knowledge of cGMP requirements is preferred.

Responsabilidades

• Support day-to-day downstream manufacturing operations in a cGMP cleanroom environment.
• Prepare buffers and process solutions according to approved procedures.
• Support chromatography operations including column packing and system setup.
• Perform filtration operations including TFF and sterile filtration.
• Complete batch records, logbooks, and GMP documentation accurately.
• Follow SOPs and report deviations to supervision.
• Assist with training, audits and process improvement initiatives.
• Support manufacturing readiness activities and inspections.

Conhecimentos

Attention to detail

Documentation practices

Communication skills

Teamwork

cGMP knowledge

Biopharma process understanding

Formação académica

Bachelor's degree in Biotechnology/ Biochemistry/ Chemical Engineering/ Life Sciences

High School Diploma/GED with 4+ years biopharma experience

Ferramentas

Chromatography systems

Tangential Flow Filtration (TFF)

AKTA chromatography platforms

Single-use technologies

Aseptic processing

Buffer preparation

Descrição da oferta de emprego

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

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, including buffer preparation, chromatography, filtration, equipment setup, cleaning, and aseptic manufacturing activities.
• 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 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.