LL01-062025 Validation Specialist for Biotech and Aseptic Process

5 days ago

Juncos PR, United States Validation & Engineering Group Full time

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:

  • Validation Specialist

Qualifications:

  • Bachelor's Degree in Science or Engineering.
  • Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in qualification and validation of facilities, utilities, drug substance, filling, inspection, and / or packaging areas for the Biotechnology industry.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • 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.
  • Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
  • SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
  • Experience with Kneat, CDOCs
  • Strong Knowledge in Media Fills, Aseptic Techniques, EMPQ.
  • Experience in Bioreactors, Fermentators, Aseptic Fill Finish, Filtration Systems, Centriguges.
  • Experience in Cleaning & Sterility Equipment such as Autoclave, CIP.
  • Experience in Environmental Control such as Laminar Flow, EMPQ.
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.

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