LL01-062824 Validation Specialist

3 days ago

Raleigh, North Carolina, United States Validation & Engineering Group Full time

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following areas:

  • Process Equipment and Utilities IQ/OQ
  • Computer System Validation (CSV)
  • Experience with the qualification of several of the following equipment and processes:
  • HVAC, environmental monitoring, Laminar Flow Hoods, CIP/SIP skids, Freezers, Parts Washers, Autoclaves, Isolators, Vacuum Pumps, Debagger, Delidder, Syringe Filling Machines, Syringe Inspection, Peristaltic Pumps, Gas Monitoring, Filter Integrity Testers, VHP Generators, Material Transfer Isolators, Check Weighs, Portable Tanks, Oxygen Sensor, Heat Exchangers, PH Meter, TCU, Scales/Balances, Sterilization and decontamination processes with VHP generators, Automation Control Systems, BAS systems.
  • Able to work independently.

Qualifications:

  • Bachelor's Degree in Science or Engineering
  • Minimum of 4 years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in IOQs within direct process / manufacturing areas.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).
  • Kneat experience valuable.

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