Validation Engineer
Core
Develop and execute validation protocols, risk assessments, and reports for equipment, utilities, and facilities to ensure medicines are manufactured to highest quality and safety standards.
Role type
Validation Engineer (Biopharmaceutical Manufacturing)
Builds
Validated manufacturing equipment, utilities, facilities, and sterilization programs (autoclaves)
Domain
Biopharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IQ/OQ/PQ protocol development, autoclave cycle development, risk assessment, CAPA analysis, regulatory guideline interpretation, change control review, validation planning
Preferred skills
Sterilization program qualification, FDA/EMA regulatory expertise, cross-functional coordination
Technologies
IQ/OQ/PQ frameworks, cGMP systems, autoclave control systems
Responsibilities
Develop and execute validation protocols and reports for equipment, utilities, and facilities; Perform risk assessments and develop validation strategies based on regulatory guidelines; Coordinate validation activities with cross-functional teams; Analyze validation data, identify deviations, and recommend CAPAs; Prepare and present validation summaries to auditors; Support regulatory inspections and internal audits; Maintain validation plans and schedules.
Seniority
Mid-level, hands-on IC
