CQV Engineer / Qualification & Validation Engineer 80-100% (m/f/d)
Core
Qualify and validate process engineering equipment and facilities in a GMP environment to ensure flawless operations and premier standards.
Role type
CQV Engineer / Qualification & Validation Engineer
Builds
Commissioning and qualification documents for new plants, including PQs for critical systems
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, commissioning, qualification, validation, deviation management, change management (GEP), CAPA implementation, audit preparation
Preferred skills
COMOS, DMS, Kneat, TrackWise, SAP
Responsibilities
Develop and maintain commissioning and qualification documents for new plants, Supervise and resolve deviations, Coordinate efforts between internal teams and external service providers, Present qualification documents during audits and inspections
Seniority
Mid-level, hands-on IC
