Job Title: Validation Engineer
Location: Fremont, CA – 94538
Duration: 7 Months ( High chances of extension)
- Provide manufacturing and validation engineering support by performing validation/qualifications in support of the established site wide Validation Master Plan.
- Generating validation deliverables, executing validation or qualification documents, leading validation project teams and overall support of the validation project schedule.
- 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 and validation plans as well as generate validation lifecycle documents.
- Provide input to the Facilities Department on preventive maintenance and calibration requirements, including setting appropriate calibration tolerances and frequency of calibration.
- Manufacturing and Quality departments to develop and train on standard operating procedures and work instructions.
Roles and responsibilities:
- Demonstrated experience in facility/utility/equipment qualification and process validation. Skilled in the setup and calibration of a Kaye Validator for temperature mapping studies.
- Conduct validation or qualification tests of new or existing equipment.
- Good understanding of ISO 13485 and FDA 820 requirements relating to product realization and process validation.
- Conduct risk assessments for equipment and processes.
- 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.
- Revalidation requirements for any equipment modifications or process changes.
- Bachelor’s Degree in a field of science.
- Engineering degree is preferred.
- 5 years of experience in the cGMP regulated industry.
- In-vitro diagnostic experience preferred.