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Insight Global

Pharma Ops Engineer

Insight Global, Rahway, NJ, United States


Must-haves

  • Bachelor's degree in engineering / science -- required

  • 2-4 years of experience in a pharmaceutical setting

  • Knowledge of cGMP policies and procedures

  • Qualification and validation documentation preparation and execution

  • Experience with Calibration and Maintenance support

  • Experience with Equipment and Computer system periodic reviews

  • Change Management and Investigation support experience

  • Experience with SAP/ProCal/Trackwise (or similar) Project Management System is a plus

Plusses

Day-to-Day

  • A pharmaceutical client in Rahway, NJ is searching for a Pharma Ops (CQV) Engineer to support the t Pharmaceutical Operations & Clinical Supply organization. This individual is responsible for providing engineering support to Pharmaceutical Sciences projects and initiatives, ensuring compliance and support primarily for the Laboratory areas but can be expanded to Pharm-Ops capital project support. This includes understanding GMP Quality systems as well as preparing and executing equipment / analytical system qualifications and validations. Additionally, a successful candidate will have experience in calibration and/or maintenance of pharmaceutical processing equipment.