Validation Engineer

Job Duties

Engage in generation, execution, oversight, commissioning, qualification, and creation of validation protocols for facilities, utilities, equipment, and computerized systems. Execution of IQ/OQ protocols. Prepare discrepancy generation, report generation, and analyze results and implement changes. Generate validation deliverables including traceability matrices, assessments, and supporting documentation. Prepare validation protocols, including validation master plans, user requirements and specifications, functional specifications, validation reports and Requirement Traceability Matrix ((RTM) per approved policies and procedures. Review Vendor generated validation protocol packages and communicate with vendors in resolving punch lists. Generate complex validation protocols using risk based approach meeting current regulatory standards and industry practices. No prior employment experience required. Minimum of a Master's Degree in Mechanical Engineering is required. Work location is Farmington Hills, Michigan with business travel and / or relocation to unanticipated US locations required.