Engineer III, Validation
Core
Perform validation activities including drafting, executing, reviewing, and approving quality documentation for clinical and commercial drug substance manufacturing of cell and gene therapy products.
Role type
Senior IC validation engineer (cGMP)
Builds
Validation documentation, protocols, and reports for manufacturing systems and processes
Domain
Biopharmaceutical manufacturing (cell and gene therapy)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, validation protocol development, data integrity, regulatory gap analysis, deviation investigation, SOP authoring, risk assessment, change control, audit support
Preferred skills
single use technology, process/facility design, clean room gowning, aseptic filling, bioreactor operation
Technologies
cGMP equipment (isolators, autoclaves, bioreactors, chromatography, TFF skids), computer systems (21CFR Part 11)
Responsibilities
Draft and approve User Requirement Specifications, Commissioning protocols, IQ/OQ/PQ, and Final Reports; Analyze validation test data to verify system compliance; Lead multi-functional teams for CQV efforts; Support internal and external regulatory inspections; Author and maintain Validation Master Plans and SOPs; Collaborate with Manufacturing, QA, and QC teams
Seniority
Senior, hands-on IC
