Validation Engineer - Equipment Qualification
Edison-New Brunswick Metro Area, NJ
- BS in Engineering or related discipline
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Executes equipment calibrations, maintenances, repairs, and requalification activities in both laboratory and manufacturing areas.
- Supervises vendors for Calibration, preventative maintenance, and qualification functions.
- Reviews and approves vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to Regulations
- Ensures all calibration, PM, and qualification records are filed appropriately after approval.
- .Writes and supports deviations and investigations that result from qualification failures along with developing and supporting the implementation of corrective and preventative actions. (CAPA)