Staff Engineer, MSAT Validation
Core
Lead validation activities for sterile and aseptic manufacturing processes, including process validation, cleaning validation, and media fill simulations to maintain a validated state.
Role type
Staff Engineer, Validation (Pharmaceutical/Biotech)
Builds
Validated manufacturing processes and contamination control strategies for sterile products
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
cGMP compliance, aseptic processing, contamination control, validation lifecycle management, risk-based validation strategies, technical writing, data analysis, problem-solving
Preferred skills
Experience with FDA/EMA regulatory expectations, audit support, cross-functional collaboration (via careerplan.io/jobs/R-01370075-staff-engineer-msat-validation-at-thermofisher)
Technologies
None explicitly listed
Responsibilities
Lead process validation (PPQ), cleaning validation, and media fill activities; Develop validation strategies using lifecycle and risk-based approaches; Author and execute validation protocols, reports, and risk assessments; Support investigations, deviations, change controls, and CAPAs; Partner with Manufacturing, Quality, and Regulatory teams; Ensure alignment with global regulatory expectations; Support internal and external audits and inspections
Seniority
Staff, technical leadership