Process Engineer I/II (MSAT)

About the role

We are currently recruiting for a Process Engineer II to join our MSAT team. You will lead the assessment and technology transfer of new manufacturing processes supporting clinical and commercial manufacturing.

Responsibilities

• Provide Upstream (cell culture) technical support (cell expansion, 50 – 500 L bioreactors, and transfection) in a GMP manufacturing environment
• Contribute significantly to technology transfers, process introductions and cross-functional activities, taking ownership of assigned workstreams as appropriate
• Draft and review technical documentation—tech transfer plans, protocols, impact assessments, change actions, process descriptions, and reports
• Support facility fit, process troubleshooting, gap analysis and risk assessments (FMEA)
• Drive process improvements to enable efficient, compliant manufacturing
• Closely collaborate with cross-functional groups including Manufacturing, Engineering, Quality, Process Development and Supply Chain
• Support raw material assessments by understanding material criticality, specifications, supplier or lot variability, GMP controls, and potential process impact
• Support BOM alignment by reviewing raw materials, consumables, quantities, specifications, and process-use points to ensure technical accuracy and manufacturing readiness

Requirements

• BS/MS in Engineering, Biological Sciences, or related field
• Minimum 3 years’ experience in biologics or pharmaceutical manufacturing (GMP environment)
• Strong understanding of bioprocess operations and equipment
• Excellent problem-solving, teamwork, organization and communication skills
• Demonstrated ability to author, review, and adhere to SOPs, batch records, and controlled documents in accordance with GMP requirements
• Flexibility to support 24/7 operations and occasional travel (~10%)
• Experience with cell or gene therapy manufacturing
• Familiarity with FDA/EU GMP standards
• Knowledge of data/statistical software (e.g., JMP, Skyland Analytics)

Qualifications

• Desirable: Knowledge of downstream processing operations and/or DP

Skills

• Desirable: Knowledge of downstream processing operations and/or DP

Benefits

Competitive total reward packages, wellbeing programs, career development opportunities, supportive, inclusive, and collaborative culture, state-of-the-art labs and manufacturing facilities, future-focused and growing fast.

Pay

Details TBD

Schedule

Details TBD