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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.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.
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