Validation Engineer/Specialist

Company: Gabriel & Associates
Location: Thousand Oaks
Posted on: March 26, 2020

Job Description:

Gabe, Inc. -- is in need of a Validation Engineer/Specialist with experience in Commissioning, Qualification and Validation of system and hardware components associated with analytical lab instruments.


Education:

• 
  
• BS/BA in Information Technology/Computer Science, Biological or Clinical Laboratory or other related discipline or equivalent work experience.
  
  
  Experience:
  
  • 
    
  • 2-5 years of experience with performing validation activities (preferred analytical equipment).
    
  • Previous experience working in an FDA regulated and/or GMP environment.
    
  • Working knowledge of Data Integrity principles (CFR Part 11).
    
  • Strong analytical skills with ability to translate sometimes ambiguous data sets into actionable insights and recommendations.
    
  • Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment.
    
  • Technical understanding of clinical laboratory operations (desired).
    
    
    Responsibilities:
    
    • 
      
    • Provide leadership and support the development and implementation of EHS Generate and Execute approved protocols/summary reports for commissioning and validation activities.
      
    • Responsible for test execution, exception reporting, assisting in exception analysis and resolution in a GMP compliant manner.
      
    • Facilitate and generate Data Integrity assessments.
      
    • Facilitate and coordinate cross functional team meetings understand client needs and drive action.
      
      
      Benefits:
      
      • 
        
      • Gabe, Inc.-- offers a competitive compensation and benefits package.
        
      • Position is located at client site in client office/manufacturing space.
        
      • Normal working hours are 8:00 a.m. to 5:00 p.m. Monday through Friday, however irregular working hours should be expected during project execution.
        
      • Pay is hourly with overtime and is commensurate with qualifications and experience.
        
        
        

Keywords: Gabriel & Associates, Thousand Oaks , Validation Engineer/Specialist, Engineering , Thousand Oaks, California