Demo

CQV Engineer

Katalyst HealthCares and Life Sciences
Brooklyn, NY Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/16/2025

Responsibilities :

  • Develop commissioning and qualification protocols for HVAC, purified water systems, clean utilities, and other critical utilities according to regulatory requirements (GMP, FDA, etc.).
  • Execute commissioning and qualification activities for utilities systems, ensuring adherence to project schedules and quality standards.
  • Conduct risk assessments, impact assessments, and gap analyses related to utilities systems.
  • Coordinate with cross-functional teams including engineering, quality assurance, operations, and validation to ensure successful project outcomes.

Requirements :

  • Generate and review commissioning and qualification documentation (IQ / OQ / PQ protocols, reports, SOPs, etc.) in compliance with regulatory guidelines.
  • Participate in FAT / SAT (Factory Acceptance Testing / Site Acceptance Testing) activities for utilities equipment and systems.
  • Troubleshoot utilities systems and equipment issues during commissioning and qualification phases.
  • Support validation activities, including process validation and cleaning validation, as needed.
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