Senior TSMS Engineer

Job Responsibilities:

• Act as SME for sterile drug product manufacturing processes including formulation, filling, lyophilization, and visual inspection.

• Analyze process data and trends to identify opportunities for improvement and ensure continued process verification (CPV).

• Lead cross-functional investigations tied to deviations, batch failures, or atypical results, ensuring timely resolution.

• Support and author lifecycle documentation including change controls, risk assessments, process validation protocols, and APRs.

• Collaborate with QA, Engineering, MSAT, and Manufacturing to optimize tech transfer, scale-up, and ongoing production support.

• Represent TSMS during audits and inspections, preparing documentation and serving as the technical lead during reviews.

Qualifications:

• B.S. or M.S. in Chemical Engineering, Biotech, or a related discipline.

• 5+ years of experience in GMP manufacturing support within pharma or biotech.

• Experience with aseptic techniques, sterile barrier systems, and regulatory frameworks (FDA, EMA, ICH).

• Strong communication and root cause investigation skills.