CQV Engineer

3 days ago

india Pharmatek Consulting Inc Full time
Job Description
  • 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

Requirements
Cell & Gene Therapy , Validation, IQ, OQ, CFR, FDA, GMP

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