Process Development Engineer - MSAT
Core
Supports biotechnology and pharmaceutical clients with robust equipment and process validation, technology transfer, troubleshooting, and manufacturing optimization.
Role type
Senior IC process development engineer (GMP)
Builds
Validated manufacturing processes, control strategies, and technology transfer packages for drug substance
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Process validation, Cleaning validation, Equipment validation, Technology transfer, Root-cause analysis, Design of experiments (DOE), Scale-up, ICH Q8/Q9/Q10 principles, FMEA, Control strategy development
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare validation or performance qualification protocols, specifications, and associated documentation for new or modified manufacturing processes, systems, or equipment; Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards; Develop validation master plans, process flow diagrams, test cases, or standard operating procedures; Develop and document process understanding strategies aligned with ICH Q8 principles, including design space definition, parameter interaction mapping, and control strategy justification; Execute quality risk management activities compliant with ICH Q9, including failure mode and effects analysis (FMEA), risk assessment, risk control implementation, and risk communication; Establish and implement integrated control strategies combining unit operation controls, in-process controls, and end-product specifications as defined in ICH Q10; Lead investigations and perform troubleshooting following process deviations, trends, or issues, including designing and performing development studies at small- or full-scale to support technology transfer or investigations; Design and execute cleaning validation and optimization studies; Conduct root-cause analysis and drive corrective actions; Lead the transfer of drug substance processes to and from manufacturing facilities; Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems; Partner with regulatory affairs to ensure validation strategies and control strategies meet current FDA expectations and ICH Q8/Q9/Q10 guidelines
Seniority
Senior, hands-on IC
