CQV Engineer (Indianapolis)Technical Source • Indianapolis, IN, United States
CQV Engineer (Indianapolis)
Technical Source • Indianapolis, IN, United States
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job_description.job_card.job_description5+ 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. Bachelors degree in Science or Engineering
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 :
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