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Validation Engineer II - MSAT

Company: Planet Pharma
Location: Vacaville
Posted on: August 2, 2022

Job Description:

Summary

Provide Commissioning and Qualification (C&Q) Support to Vacaville Manufacturing operations for project delivery and operational support, focused on the Qualification Lifecycle Document Remediation project.

Job Responsibilities

Technical

  • Completion of all applicable training requirements required to support project activities
  • Work with cross-functional teams to support development of Qualification Plan and Summary
  • Support in the development of design and risk assessment documents
  • Leverage risk management principles to drive risk-based validation testing and decision-making.
  • Development, approval, and execution of qualification deliverables for the completion of Commissioning & Qualification (C&Q) activities in accordance with procedures and approved Qualification strategy
  • Support development and execution of planned and unplanned events
  • Review, and revise Qualification Lifecycle documents
    Job Requirements

    Education
    • Bachelor's degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job experience.
      Experience (may vary depending on site size/scope)
      • Four or more years of validation experience (or equivalent experience) in a cGMP environment for a wide range of validation projects including validation of large-scale biochemical manufacturing equipment, utility and facility 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 individual as well as larger scale projects.
          Work Environment/Physical Demands/Safety Considerations
          • Vigilant to safety and maintains a safe environment for all during 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.
            The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Keywords: Planet Pharma, Vacaville , Validation Engineer II - MSAT, Engineering , Vacaville, California

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