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

Company: HireTalent - Diversity Staffing & Recruiting Firm
Location: Vacaville
Posted on: August 2, 2022

Job Description:

Job Description

Job Title: Validation Engineer II

Job Location: Vacaville, CA

Job Duration: 24+ Months (W2)

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 Genentech 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.
                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 an
                
                accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties
                
                and 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