MS&T Process Engineer
Core
Support technology transfer, process implementation, commissioning, qualification, and validation activities within a GMP-regulated sterile manufacturing environment.
Role type
MS&T Process Engineer
Builds
Compliant and efficient manufacturing solutions for sterile fill-finish operations
Domain
Life Sciences / Biopharmaceutical Manufacturing
Required skills
GMP compliance, technology transfer, commissioning, qualification, validation, risk assessment, change control, fill-finish operations, aseptic processing, vendor qualification, process optimization
Preferred skills
Engineering or Life Science degree, stakeholder management, project coordination
Technologies
DQ, FAT, SAT, IQ, OQ, PQ, PV protocols, CQV documentation, SOPs, validation strategies
Responsibilities
Lead technology transfer activities and support facility/process upgrades; Author and review validation protocols (DQ, FAT, SAT, IQ, OQ, PQ, PV); Develop CQV documentation and validation strategies; Coordinate cross-functional teams for operational readiness; Support fill-finish manufacturing processes (vial filling, lyophilisation, sterile filtration); Provide technical support for vendor qualification and troubleshooting