CQV Engineer Job at Technical Source, Indianapolis, IN

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  • Technical Source
  • Indianapolis, IN

Job Description

Technical Source is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for aseptic filling equipment and isolators. This role requires a self-starter with a strong understanding of the CQV lifecycle and the ability to own and drive project scopes independently.

Key Responsibilities:

  • Develop and execute IQ/OQ/PQ protocols for aseptic fill lines and isolators.
  • Support full CQV lifecycle documentation, including protocol generation, field execution, and summary report creation.
  • Collaborate on FAT/SAT, URS, design reviews, walkdowns, and troubleshooting.
  • Utilize KNEAT paperless validation software (strongly preferred).

Required Experience:

  • 5+ years CQV experience in a pharmaceutical environment, specifically on aseptic filling equipment projects.
  • Hands-on experience commissioning new equipment and systems
  • Proven ability to work independently and manage project scopes with minimal oversight.
  • Bachelor’s degree in Science or Engineering

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