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Technical Source

CQV Engineer (Indianapolis)

Technical Source, Indianapolis, Indiana, United States, 46262

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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. Bachelors degree in Science or Engineering