Equipment Engineer - Validation & Qualification
Newark Metro Area, NJ
BS in Engineering or Science related discipline preferred.
Minimum 2 years of experience in FDA-regulated industry preferred.
Instrumentation background and experience in laboratory and manufacturing operations.
Knowledge of cGMP in the pharmaceutical industry.
Minimum 2 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
Excellent computer skills including knowledge of calibration management and environmental monitoring systems.
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