MSAT Engineer

Job Responsibilities:

• Execute tech transfer of upstream or downstream processes into GMP manufacturing, including equipment fit assessments and batch record development.

• Support PPQ execution, cleaning validation, and process validation studies for new product introductions.

• Collaborate with R&D, Engineering, and QA to ensure seamless transition from development to commercial scale.

• Lead investigations tied to process deviations, excursions, and non-conformances from a technical perspective.

• Author technical documentation, including protocols, risk assessments, and summary reports to support regulatory filings.

Qualifications:

• B.S. in Chemical Engineering, Biochemistry, or related discipline.

• 3–6 years of MSAT or process engineering experience in a biologics or sterile pharma facility.

• Familiarity with bioreactors, chromatography skids, and buffer/media preparation equipment.

• Understanding of FDA/ICH guidelines for process validation and lifecycle management.