Senior Validation Engineer
Core
Lead and execute qualification and validation activities for equipment, facilities, utilities, and computerized systems in a biopharmaceutical production facility to ensure regulatory compliance and product quality.
Role type
Senior Validation Engineer (Biopharmaceutical Manufacturing)
Builds
Validated equipment, facilities, utilities, and computerized systems for biopharmaceutical production
Domain
Biopharmaceutical manufacturing / GxP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation principles (IQ/OQ/PQ/CSV), Risk assessment (FMEA), GMP environment experience, Biopharmaceutical manufacturing knowledge, Technical writing, Regulatory knowledge (FDA/EMA/ICH)
Preferred skills
Quality assurance, Quality management, Computerized maintenance and validation systems (Kneat Gx, ValGenesis, TrackWise, Veeva QualityDocs, SAP PM, IBM Maximo, LIMS, MES)
Responsibilities
Develop and execute validation plans and protocols; Act as subject matter expert and mentor; Perform risk assessments; Collaborate with cross-functional teams; Investigate and resolve validation deviations; Participate in internal and external audits; Support training and process improvement
Seniority
Senior, hands-on IC with mentorship
