Newark Metro Area, NJ
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.
Strong written and verbal communication skills.
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,
BS / MS Engineering with 3+ years of Pharmaceutical industry experience
Shift requires The schedule will be Friday-Tuesday or Thursday-Monday with a work shift of 8:30am - 5pm.