Validation Engineer_Efu/Csv

The Validation Engineer IV position is responsible for defining qualification/validation strategies and coordinating testing activities required to complete assigned projects in support of the operation of the Vacaville Commercial Manufacturing Facility. Performance of such validation activities includes Equipment/Utility/Facility Qualification, Cleaning Validation, Steaming/Sanitization/Sterility Validation, and Computer Systems Validation across the entire validation lifecycle from Plan to Retire. Technical:

• Develop, and optimize the validation strategies for equipment, facility & utility systems, and computerized systems.
• Leverage risk management principles to drive risk-based validation testing and decision-making.
• Author Project Plans, Protocols, and Summary reports; and maintain compliance with new PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
• Review Validation Protocols, Commissioning Plans, analyze test results and review summary reports.
• Represent the department on project teams and coordinates activities of Engineering Sciences and Technology, Manufacturing, Quality, and other Vacaville groups required to manage projects.
• Ensure validation documentation is consistent with industry regulations and standards when supporting projects as a contractor.
• Participate in the efforts to evaluate gaps, develop remediation plans, and drive remediation through the Planned/Unplanned Events system for development and deployment of new Roche PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
• Provid e technical assessments and validation review of Automation Functional Requirements, Control Qualification testing (recipes, I/O, control module, etc.), P&IDs, engineering changes, and associated start-up documentation; in addition to validation review for engineering, process, and standard operating procedure changes
• Promotes good interdepartmental relations.
• Training is maintained to ensure job responsibilities can be performed on a daily basis.

Education:

• Bachelor's degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job experience.

Experience:

• 9 or more years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large-scale biochemical manufacturing, utility and automation systems.

Knowledge/Skills/Competencies:

• Has advanced knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations, and industry trends.
• Strong technical writing, verbal communication, interpersonal and problem-solving skills.
• Ability to work independently, organize, and manage individuals as well as lead larger-scale projects and track progress against defined milestones, budgets, and schedules.

• Vigilant to safety and maintains a safe environment for all during the performance of job responsibilities (i.e. Validation Field Execution).
• Need to be able to lift 50 lb or greater and work in a cleanroom environment for long periods of time.
• Need to be able to pass vision exam to support visual inspection of equipment.