CQV Engineer

4 weeks ago

Brooklyn, United States Katalyst Healthcares and Life Sciences Full time

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.
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.