CQV Engineer

• Designing validation plans.
  
• Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
  
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
  
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
  
• Running test scripts and documenting results
  
• Adherence with project schedule for all assigned activities
  
• Maintaining clear, detailed records qualification and validation
  
• Documenting impact and risk assessments as part of a team
  
• Completing user interface testing, software verification, and complete alarm testing on automated systems
  
• Developing, reviewing, and executing testing documentation
  
• Making recommendations for design or process modification based on test results when executing test scripts
  
• General understanding of capital equipment implementation and process knowledge
  
• Understanding validation documents, URS, IQ, OQ, PQ
  

Requirements

• Must be willing to work onsite in The Woodlands, TX (Houston area)
  
• 5 -7 years of demonstrated CQV experience in GMP regulated (preferably Cell and Gene Therapy) environments
  
• Obvious business maturity and interpersonal skills to be able to communicate effectively and collaborate
  
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
  
• Proven attention to detail and organization in project work
  
• Capable of working on assigned tasks without mentorship
  
• GMP and Good Documentation Practice training (may be completed at onboarding)
  
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
  
• Basic skills with EXCEL and PowerPoint
  
• Strong interpersonal skills and clear communication capabilities