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 systemsProven ability to work independently and manage project scopes with minimal oversight.Bachelors degree in Science or Engineering