US_Validation Engineer II_22094_Qualification Lifecycle Document Remediation Project #: 22-06406

Company: HireTalent - Diversity Staffing & Recruiting Firm
Location: Vacaville
Posted on: August 1, 2022

Job Description:

Job DescriptionJob Title: Validation Engineer IIJob Location: Vacaville, CAJob Duration: 24+ Months (W2)SummaryProvide Commissioning and Qualification (C&Q) Support to Vacaville Manufacturing operations forproject delivery and operational support, focused on the Qualification Lifecycle Document Remediationproject.Job ResponsibilitiesTechnical

• 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 ofCommissioning & Qualification (C&Q) activities in accordance with Genentech procedures andapproved Qualification strategy
  • Support development and execution of planned and unplanned events
  • Review, and revise Qualification Lifecycle documentsJob RequirementsEducation
    • Bachelor's degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMPjob experience.Experience (may vary depending on site size/scope)
      • Four or more years of validation experience (or equivalent experience) in a cGMP environment for awide range of validation projects including validation of large-scale biochemical manufacturingequipment, 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.Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities,skills, efforts, or working conditions associated with a job. While this description is intended to be anaccurate reflection of the job requirements, management reserves the right to modify, add, or remove dutiesand to assign other duties as necessary.

Keywords: HireTalent - Diversity Staffing & Recruiting Firm, Vacaville , US_Validation Engineer II_22094_Qualification Lifecycle Document Remediation Project #: 22-06406, Engineering , Vacaville, California