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MES Validation Engineer
Ref No.: 18-28314
Location: Concord, California
Position Type:Contract
Start Date: 04/24/2018
MES Validation Engineer - JD

•Detailed project planning specific to the validation related activities
•Utilization of a risk based approach to determine the validation requirements
•Generation, signoff & execution of various program & GMP related documents and protocols, including a number of the following: validation master plan, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls
•Configuration specifications generation detailing the specific configuration of the systems / interfaces
•Document status tracking to ensure that all the documents are being controlled accordingly
•Project change control implementation in accordance with requirements, design and system changes
•Management of deviations and tracking to closure
•Identify risks and clearly communicate them to project stakeholders
•Define problem solving and risk mitigation strategies & Identify and mitigate work-stream related issues
•Identify and support organizational change
•Support completion of work-stream activities