Senior Validation Engineer

• Supervisor Principal Validation Engineer.

• Responsible for defining qualification / validation strategies and coordinating testing activities required to complete assigned projects in support of continued cGMP operations at the Polaris Vacaville commercial manufacturing facility.

• This consists of initial qualification, requalification, periodic review and Validation activities associated with capital/expense projects.

• Performance of such validation activities includes equipment, utility, facility qualification, cleaning validation, steaming/sanitization sterility validation, and automation system qualification across the entire validation lifecycle from the planning phase through retirement.

• The Validation Project Manager should develop and maintain effective metrics and tracking tools to ensure successful planning and execution of Validation-related activities.

• Leadership and People Management.

• Provide project/technical leadership and manage the activities of assigned internal and contract validation personnel and ensure the quality and timeliness of completed work.

• Manage formation of validation projects/teams including developing scope documents, assessment of bid documents, presenting analysis for Validation-related projects.

• Ensure contract project teams are delivering project scope/deliverables in accordance with contractual obligations including tracking and reporting adherence to cost/budget, schedule, and scope.

• Assist in planning and execution to support requalification and periodic review requirements leveraging internal and contract personnel.

• Responsible for oversight and performing assigned Commissioning, Qualification, and Validation of equipment, utility systems, automation systems, processes and facilities.

• Author, review, and/or approve Validation Master Plans, Validation Project Plans, and Commissioning Project Plans.

• Author, Review, and/or Approve Commissioning Plans, Commissioning Protocols, Validation Plans, Validation Protocols; analyse and approve test results; review and/or approve summary reports generated by internal and contract personnel.

• Perform testing, collects samples, analyses test results, and prepare Commissioning and Qualification summary reports when required.

• Support preparation of specific validation summary sections of regulatory submissions and present equipment and cleaning validation packages to regulatory authorities during routine and pre-approval inspections.

• Lead efforts by representing the Validation department on project teams and coordinates activities of Manufacturing Sciences and Technology, Manufacturing, Quality, and other Vacaville groups required to manage projects.

• Serves as a technical consultant and provides guidance to the MSAT Validation group in the areas of Commissioning and Qualification of equipment, utility systems, automation systems, processes, and facilities.

• Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.

• Develop and optimize project-based resource assessments in addition to validation strategies for equipment, utility systems, automation systems, processes, and facilities.

• Drive implementation of continuous improvement initiatives within Validation to gain process efficiencies and maintain a state of inspection readiness and regulatory compliance.

• Ensure contract and Polaris staff are compliant with company policies and procedures as applicable.

Requirements:

• BA/BS degree in Sciences, Engineering or other technical field.

• Minimum of 10 years of experience in the biopharmaceutical industry including 5 or more years with equipment qualification, including experience in authoring/reviewing validation documentation (URS, Risk Assessment, IQ/OQ/PQ and summary reports).

• Strong background and understanding of FDA regulations.

• Knowledge and experience with Risk Based Approach to commissioning and qualification.

• Must have thorough knowledge of manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.

• Superb verbal and written communication skills.

• Must clearly communicate complex ideas to varied audiences that include engineers, scientists, technicians, and executives as well as persons with non-technical backgrounds.

• Proven ability to set & drive organizational objectives through directing & influencing others.