MF01-010624 C&Q Specialist for Multiple Facility Qualifications and Utilities

3 weeks ago

, United States Validation & Engineering Group Full time
Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who 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 a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • C&Q Specialist for Multiple Facility Qualifications and Utilities
    • Various GMP Suites
    • Support Areas
    • HVAC, Chilled Water, Reheat Water, Compressed Air, Steam, Potable Water, Process Waste

Qualifications:

  • Bachelor's Degree in Science or Engineering.
  • Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in direct process / manufacturing areas.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
  • Experience with Facilities Qualifications, Risk Assessments, Traceability Matrix and IQ, OQ, PQ protocols development and execution, deviations and reports generation
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.

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