Validation Engineer

Company: Nesco Resource ( Learn More )

General Information
US-CA-Fremont
N/A
Not Specified
Full-Time
Not Specified
Not Specified
False
False
Job Description

Job Description

Validation Engineer


  • 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




  • Requirements


  • Bachelor Degree in a field of science.

  • Engineering degree is preferred.3 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.

  • Job Requirements