MS&T Process Engineer - Biopharma Tech Transfer & CAPA

System One, Inc.; Princeton (NJ); Sur place; USD 68 000 - 97 000; Temps partiel

Avantages offerts par ce poste

Health benefits and 401(k) plan

On-site work

Résumé du poste

System One, Inc. seeks a Process Engineer MS&T for contract-to-hire at its Princeton, NJ site. The role provides on-site manufacturing process support, tech transfer, and CAPA ownership, with responsibility for batch records, SOPs, and regulatory compliance.

The candidate should have a BS or higher in science or chem/biomedical engineering, 5+ years in GMP biologics or cell therapy manufacturing, and strong knowledge of cGMP and 21 CFR parts. The position offers up to $60/hour.

Qualifications

• BS degree or Advanced degree in Science or Chem/Bio Engineering.
• Minimum 5+ years of industry experience.
• Minimum 3+ years GMP biologic/cell therapy manufacturing process support.
• Scientific understanding in bioprocessing principles.
• Familiarity with cell therapy processes and cGMP.
• Experience with equipment qualification and validation strategies and methodologies.
• Understanding of 21 CFR Part 11 and 21 CFR Parts 210 and 211 cGMP regulations.
• Experience interfacing with clients and cross-functional teams.
• Experience with startup/validation/licensure of new biopharmaceutical manufacturing facilities is a plus.
• Experience with data aggregation, processing and analysis software is a plus.

Responsabilités

• Serve as technology and process SME on the floor.
• Provide on-the-floor and on-site technical support to manufacturing.
• Author, review and approve batch records and SOPs.
• Author and approve protocols and reports per regulatory expectations.
• Analyze and summarize manufacturing data for impact assessments and investigations.
• Own change controls for process and procedure changes.
• Lead CAPA system investigations.
• Lead tech transfer for new processes and product implementation.
• Perform tech transfer facility fitness, gap analysis, and risk assessments.
• Apply continuous improvement tools to close procedural and compliance gaps.
• Identify opportunities for process improvements and lead implementation.
• Interface with Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
• Support equipment and systems validation activities; review qualification docs; draft URS; participate in impact assessments.
• Perform gowning activities and enter manufacturing plant.

Connaissances

Bioprocessing principles

cGMP

Data analysis

GMP manufacturing

Equipment qualification

21 CFR Part 11 familiarity

Client interfacing

Cross-functional collaboration

Formation

Bachelor's or Advanced degree in Science or Chem/Bio Engineering

Outils

Data Historian

Distributed Control Systems

Statistical software

Program management software

Description du poste

System One, Inc. seeks a Process Engineer MS&T for contract-to-hire at its Princeton, NJ site. The role provides on-site manufacturing process support, tech transfer, and CAPA ownership, with responsibility for batch records, SOPs, and regulatory compliance.

The candidate should have a BS or higher in science or chem/biomedical engineering, 5+ years in GMP biologics or cell therapy manufacturing, and strong knowledge of cGMP and 21 CFR parts. The position offers up to $60/hour.