Job ID :
US - California - Fremont
Validation Engineer Job Description
- Generate, execute and report on protocols for the qualification of facilities/utilities/equipment and validation of manufacturing processes.
- Assist in the development of user requirements for new equipment acquisitions.
- Conduct risk assessments for equipment and processes.
- Develop validation strategies based on regulatory requirements, scientific rationale, industry practice and assessed risk.
- Perform P&ID and I/O verifications.
- Participate in FAT, SAT, commissioning and startup of new equipment.
- Provide project updates to supervisor/manager. Escalate issues and provide recommendations for resolution.
- Assess the revalidation requirements for any equipment modifications or process changes.
- Provide input to the Facilities Department on preventive maintenance and calibration requirements, including setting appropriate calibration tolerances and frequency of calibration.
- Work with the Manufacturing and Quality departments to develop and train on standard operating procedures and work instructions
- Bachelor Degree in a field of science. Engineering degree is preferred.
- 5 years of experience in the cGMP regulated industry. In-vitro diagnostic experience preferred.
- Demonstrated experience in facility/utility/equipment qualification and process validation.
- Skilled in the setup and calibration of a Kaye Validator for temperature mapping studies.
- Good understanding of ISO 13485 requirements relating to product realization and process validation.
- Good analytical skills and ability to communicate effectively with all levels.
- Proficient in Microsoft Word and Excel.
- Good understanding of statistical techniques is a plus.
Join our Talent Community
If you're ready to make a difference in the world, you can do it here.Join