Engineer- Instrument Qualification
Edison-New Brunswick Metro Area, NJ
BS in Engineering or Science related discipline preferred.
Minimum 10 years experience in FDA-regulated industry
4 years experience in a quality assurance related discipline preferred.
Advanced 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.
In depth knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP.
Excellent computer skills including knowledge of calibration management and environmental monitoring systems
Supports the successful operation of facility, laboratory and business functions at multi use sites through interaction with internal team members and peer level customers as well as external service providers. The incumbent in this individual contributor role ensures the compliance of equipment and the Equipment Calibration group with local, global and regulatory guidelines. The incumbent will perform periodic reviews of equipment, policies and procedures, gap analysis where required, small and large scale projects in order to complete departmental objectives.