Validation Engineer III - US


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Job Title: Validation Engineer III
Job ID: 56215
Location: Carlsbad CA 92008
Duration: 6+ Months

Job description:
Leads the development and execution of qualification and validation protocols for equipment, and processes.
Determines qualification/validation requirements based on risk.
Leads the Validation Change Control process and Validation Review Board.
Works with outside vendors and equipment owners to coordinate equipment calibration, PM, repairs and validation.
Works with Des Plaines, IL site to align equipment and validation programs used in diagnostic product development.
Works with corporate Global Engineering on company standards and calibration outsourcing.
Assures compliance to in-house and/or external specifications to standards, such as ISO and GMP regulations.
Helps train others in ISO 9001, ISO 13485 and GMP standards and quality procedures.
Participate on internal audit team and lead external audits for the equipment and validation quality system elements.

Experience / Skills Needed
BS Degree in engineering or area of science (e.g. Biology, Chemistry, Physics, etc.)
Requires knowledge of ISO 9001, ISO 13485 and 21 CFR Part... View Full Description

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