Validation Engineer II

Summary

The Validation Resource for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP‑regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), clean rooms, compressed gases, and other support utilities. This resource must ensure compliance with industry standards and regulatory requirements while working closely with cross‑functional teams to support new installations, system upgrades, and operational readiness.

• Plan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed gases) and facilities (e.g., clean rooms, environmental monitoring systems).
• Troubleshoot and resolve technical issues during the commissioning phase.
• Author, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.
• Validate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.
• Ensure systems meet performance requirements and GMP standards.
• Perform thermal mapping, pressure testing, and other critical tests as needed.
• Develop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.
• Document deviations, CAPAs, and change controls associated with facilities and utilities systems.
• Ensure traceability of qualification activities in alignment with the Validation Master Plan (VMP).
• Ensure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).
• Perform risk assessments and develop mitigation strategies for utility and facility systems.
• Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.

• 3-5 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.
• Hands‑on experience with systems such as HVAC, purified water, clean steam, gases, and clean rooms.
• Familiarity with environmental monitoring and building management systems (Client).
• Manufacturing plant and utility environments, including clean rooms.
• Flexibility to work extended hours or weekends during critical project phases.