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Form of workJob Description
Title: Validation Engineer IV
Location: Vacaville, CA
Duration: 12 Months on W2
Summary:
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:
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.
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:
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.
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 clean room environment for long periods of time.
Need to be able to pass vision exam to support visual inspection of equipment.
Location: Vacaville, CA
Duration: 12 Months on W2
Summary:
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:
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.
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:
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.
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 clean room environment for long periods of time.
Need to be able to pass vision exam to support visual inspection of equipment.
