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Job Description

Kelly Scientific Resources is currently recruiting for a Validation Manager to be responsible for managing, in conjunction with the Quality and Compliance department, the Washington Immunotherapy Manufacturing Facility with current FDA regulatory requirements. Responsibilities include, but are not limited to: ' Develop, hire and manage the Validation Department for the Seattle ' Immunotherapy Manufacturing Facility for clinical and commercial manufacturing ' Write and keep a WA Facility Validation Master Plan current ' Define equipment/software system requirements and specifications ' Develop equipment, cleaning, process, software, automation, or computerized system validation plans as needed ' Create corporate and local standard operating procedures (SOPs) for validation various validation activities ' Prepare or review and approve validation protocols and final reports (IQ, OQ, PQ) ' Coordinate the proper approval and executions of plans and protocols ' Execute various validations ' Maintain hardcopy and/or electronic controlled validation documentation ' Conduct training for Dendreon employees on validation policies and procedures as needed ' Support the Dendreon QA/Compliance department in any regulatory inspections or audits ' Work with QA/Compliance to track and coordinate any validation change control and/or corrective actions ' Document deviations, system failures and corrective actions ' Support Facilities/Engineering and Operations to keep a high level of compliance ' Manage contract validation consultants and validation execution by third party Requirements: ' BS or MS in Life Science, or a Technical/Engineering discipline, or equivalent ' 6+ years of hands on Validation experience ' A minimum of 8+ years experience in an FDA regulated industry, Biotech is preferred ' Extremely detail oriented with a focus on quality and metrics ' Flexible and able to work off hours, overtime and in a team environment This is a direct hire position in beautiful Seattle, WA. Please email your resume to [Click Here to Email Your Resumé] or apply on-line. Kelly Scientific is a division of Kelly Services - an international, Fortune 500 Company with a reputation for excellence. Kelly Scientific is devoted to partnering with companies to provide scientific professionals with the best possible positions to meet their career goals. For more information, visit www.kellyscientific.com.

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