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Validation Engineer III

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 820
Use of quality tools such as FMEAs, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
Ability to work within a team and influence others. This position will work with Facilities, R&D, Manufacturing, QC, etc.
Ability to make risk based decisions and effectively communicates risks to team and management.
Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Acts independently to determine methods and procedures on new assignments.

Looking for local candidates. needs someone who can create and determine if the protocol is adequate Validate Equipment Write Protocols Not a Manufacturing Facility Familiar with writing protocols from scratch Manage the calibration program. Must be familiar with calibration. Tools Experience - will be mapping for temp humidity Is open to seeing candidates over max bill rate. List bill rate (not pay rates) in supplier comment box when submitting candidates.

Candidates must possess 3-7 years experience supporting validation programs and possess a BS degree, preferable in the Science or Engineering fields (or equivalent experience). Give attention to detail, perform critical analysis of situations and provide recommendations, work independently with structured guidance, good follow up skills,

Contact Person:Manju

If you are interested in this spoition then you can reach me at 2015249600 X 7944

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