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MSAT Specialist

2 months ago

Monroe, United States Insight Global Full time

Schedule:

8am-5pm - Mon-Fri


Must Haves:

  • 6+ years in Pharmaceutical Industry (FR&D/PDL/Tech. Services/MS&T). Pharmaceutical and FDA is preferred
  • Bachelor's degree, preferably with a focus in Engineering or Pharmaceutical Science
  • Hands-on experience in Manufacturing Operation of Sterile /Parenteral formulations and related equipment such as vial washer, tunnel, filling, capper, Lyophilizer, PFS, Manufacturing and filtration vessel, labelling, Inspection, Utilities: Water for Injection Generation and distribution, Purified water Generation , Compressed air, Pure steam & Nitrogen)
  • Experience executing and writing test protocols Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Comprehensive knowledge of production processes

Plusses:

  • Experience with Trackwise
  • Knowledge of Capa and Deviations

Day to day:

Insight Global is seeking an experienced Sr. MSAT Specialist to join one of our large pharmaceutical clients for a full-time position. This position will be 5 days a week onsite, in Monroe, NC. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have experience developing validation protocols for various process equipment and systems. This individual will have to execute validation test according to established protocols (IQ, OQ, PQ).