HVAC C&Q Engineer

mai 7, 2024
Urgent
Application ends: juillet 7, 2024

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Job Description

Responsibilities:

  • Oversee the entire Commissioning & Qualification (C&Q) process for a new purification building project, including the revision and drafting of qualification deliverables such as Design Qualification, Risk Analysis (AMDEC), FAT/SAT protocols, and test sheets.
  • Ensure compliance with qualification requirements outlined in the Procurement Quality Requirements and participate in risk analysis equipment activities.
  • Coordinate and participate in testing activities as defined in approved deliverables, ensuring traceability, and tracking of non-conformities throughout all commissioning and qualification stages.sistance in the execution or verification of design qualification.
  • Verify the alignment between supplier specifications and URS of the relevant systems, coordinate supplier tests, and ensure conformity with the approved test plans.
  • Handle non-conformities independently, including impact analysis, documentation of corrective actions, and closure of non-conformity reports.
  • Ensure proper documentation and capitalization of FAT and/or SAT results, aligning with installation and operational qualification principles as outlined in protocols.

Candidate Requirements:

  • 5-10 years of practical experience in qualification of Controlled Atmosphere Zones (CAZ), with knowledge and experience of cGMP requirements from pharmaceutical standards (BPF, Eu, GMP, FDA, and AVISA).
  • Specific expertise in ISO 14644 and FD X15-140 standards.
  • Demonstrated ability to ensure personnel involved in C&Q activities are trained in Good Manufacturing Practices (GMP) and qualification practices, with a commitment to providing evidence of one-year training.
  • Proficiency in drafting, revising, and coordinating approval of qualification documents, including familiarity with regulatory compliance and industry best practices.