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Validation Engineer IV, EFU/CSV

Vacaville, CA 95688

Posted: 02/23/2024 Employment Type: Contract Job Category: Engineering Job Number: 600444 Is job remote?: No Country: United States

Job Description

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.

Job Responsibilities 

?    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.

Job Requirements

?    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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