Facilities/Utilities/Equipment Validation Specialist (IVD/Biotech)

San Jose, CA

Industry: Medical Device Job Number: 131522


Facilities/Utilities/Equipment Validation Specialist (IVD/Biotech)


Our client is a large IVD organization that manufactures In-Vitro Diagnostic products. They are currently in need of a hands-on Validation Specialist with experience in the validation of Facilities, Utilities, Equipment and Processes, to support the validation of newly acquired equipment, as well as off day-to-day validation support.

Scope & Responsibilities:

The client has recently purchased a number of new pieces of Processing Equipment that they need Qualified and Validated. This equipment includes pieces such as Gas Tanks (containing Argon & Nitrogen), CIP Systems (Clean-In-Place), Temperature Controlled Units, Filling Lines, and various other pieces of Manufacturing/Process equipment. It would be strongly preferred if this individual has IVD experience (In-Vitro Diagnostic), but experience in another cGMP regulated industry such Medical Device/Biotech/Pharmaceutical will suffice. This individual must have hands-on experience in Facilities, Utilities & Processing Equipment Qualification and Validation. Specific duties include:
  • 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.
  • Setup and calibration of a Kaye Validator for temperature mapping studies.

  • Facilities/Utilities/Equipment Validation
  • Process Validation
  • Temperature Mapping- Setup & Calibration of Kaye Validator
  • ISO 13485 requirements relating to Product Realization and Process Validation.
  • Proficient in Microsoft Word and Excel.
  • Bachelor Degree in a field of science.

  • In-Vitro Diagnostics Experience is preferred.
  • Engineering degree is preferred.
  • Good understanding of statistical techniques is preferred.

Job Type: Contract

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