Equipment Validation Engineer
Newark Metro Area, NJ
Education & Experience:
BS degree in Engineering or equivalent
Minimum 5 years of experience in FDA-regulated industry, with 3 year experience in equipment qualification.
Maintains all qualified equipment systems in compliance with policies, guidelines and procedures.
Develops qualification protocols, and associated reports while adhering to a change management process.
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions.
Develops written procedures for calibration and preventive maintenance of equipment
Supports calibration, equipment qualification and validation activities.
Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.