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What to Expect

  • Work closely with engineering teams to plan and execute commissioning activities.
  • Create detailed commissioning plans, protocols, and reports for production equipment and room qualifications.
  • Conduct thorough checks to ensure equipment and systems are fully functional.
  • Quickly identify and resolve issues that arise during commissioning.
  • Develop qualification protocols and comprehensive test plans for equipment, systems, and processes.
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Maintain meticulous documentation of qualification tests and analyze results.
  • Identify and correct any deviations from established specifications.
  • Work with cross-functional teams to resolve validation discrepancies.
  • Create and implement validation protocols for processes and systems, ensuring compliance with industry standards.

Qualifications

  • 2-3 years of technical experience as a CQV
  • Strong knowledge of industry regulations (FDA, GMP, GAMP).
  • Excellent troubleshooting and problem-solving skills.
  • Very good English language skills, both written and spoken

Tagged as: cqv engineer

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