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MF01-030424 Qualification / Validation Specialist

Department: Field - MF
Location: Cayey, 035

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:

  • Qualification / Validation Specialist for Manufacturing Equipment

Qualifications:

  • Bachelor's Degree in Science or Engineering.
  • Minimum of 5 years of experience in direct pharmaceutical, biotechnology, or preferable medical device industry.
  • 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 the development and execution of qualification protocols.
  • Experience with Risk Assessment, URS, VP, deviations generation.
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.

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