Role Title Senior Validation Engineer

Department Validation

Supervisor Principal Validation Engineer

FLSA Exempt

Salary Range $110K/yr ~ 140K/yr

CORE VALUES

Respect ? Passion ? Teamwork ? Integrity ? Honesty ? Commitment ? Collaboration

FUNCTION SUMMARY

Project Management Office

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.

Duties & Responsibilities

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.

Technical

• 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; analyze and approve test results; review and/or approve summary reports generated by internal and contract personnel.
• Perform testing, collects samples, analyzes 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.

Education & Experience

• 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
• Deep 21CFR Part 210/211 experience is preferred
• 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.