Specialist, QA Validation & Engineering
Core
Provide quality oversight for Facilities, Engineering, and Validation groups to ensure compliance with regulations and support commercial GMP manufacturing of biological drug substances and products.
Role type
Specialist, QA Validation & Engineering
Builds
Commercial GMP manufacturing of biological drug substances and products
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Knowledge of GMP, 21 CFR Parts 210/211, biological regulations (21 CFR 600s), ICH Guidelines, EU GMPs; Understanding of upstream and downstream manufacturing processes; Experience in QA function within biologic, pharmaceutical, or medical device industry
Preferred skills
Experience with IQ/OQ/PQ for controlled temperature units and biologics manufacturing equipment; Experience with facility expansion and aseptic processing; Experience reviewing and writing deviations and investigations
Technologies
bioreactors, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves, critical utilities
Responsibilities
Serve as QA liaison with Facility, Engineering, and Validation teams; Review and approve validation protocols (PPQs, engineering studies, cleaning validation); Review and approve equipment qualification protocols (IQ, OQ, PQ); Provide QA support for calibration and maintenance programs; Review corrective maintenance work orders; Review and approve deviations and assist in investigations; Support facility and equipment change management; Participate in quality and process improvement initiatives; Support client and regulatory audits
Seniority
Specialist, hands-on IC
