Validation Engineer IV, EFU/CSV
1000 New Horizons Way Vacaville, CA 95688 US
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.
? 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 PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
? Provide 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.
? Bachelor’s degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job 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.
? 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.
Work Environment/Physical Demands/Safety Considerations
? 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.
Pay Rate Range: $70-$95/hr. Salary will be commensurate with experience
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