About the job
- Senior Validation Engineer – Utilities and Facilities
Position Overview
The Senior Validation Engineer for Utilities and Facilities plays a pivotal role in ensuring the qualification and validation of essential utility systems and facility infrastructure within a GMP-regulated setting. This covers HVAC systems, water systems (including WFI and RO/DI), cleanrooms, compressed gases, and additional support utilities. The Validation Engineer ensures adherence to industry standards and regulatory mandates while collaborating with cross-functional teams to facilitate new installations, system enhancements, and operational readiness.
Primary Responsibilities:
1. Commissioning Activities
- Design and implement commissioning activities for utility systems (such as HVAC, purified water systems, clean steam, and compressed air) and facilities (including cleanrooms and environmental monitoring systems).
- Conduct Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and pre-qualification tests to validate system performance.
- Troubleshoot and resolve technical challenges during the commissioning process.
2. Qualification & Validation
- Draft, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.
- Validate critical systems, including HVAC balancing, environmental monitoring, water quality assessments, and cleanroom certifications.
- Confirm that systems fulfill performance criteria and GMP standards.
- Conduct thermal mapping, pressure testing, and other essential evaluations as necessary.
3. Documentation
- Establish and maintain precise and comprehensive documentation, including protocols, validation reports, and Standard Operating Procedures (SOPs).
- Record deviations, Corrective and Preventive Actions (CAPAs), and change controls linked to facilities and utility systems.
- Guarantee traceability of qualification activities in alignment with the Validation Master Plan (VMP).
4. Compliance and Risk Management
- Ensure that all utility and facility qualification activities comply with global regulatory requirements (e.g., FDA, EMA, WHO).
- Conduct risk assessments and develop strategies to mitigate risks associated with utility and facility systems.
- Ensure adherence to 21 CFR Part 11, Annex 11, and relevant ISO standards.
5. Lifecycle Management
- Oversee requalification and periodic evaluations of utility and facility systems.
- Manage system upgrades, decommissioning, and retrofits while ensuring compliance with GMP regulations.
- Collaborate with engineering and maintenance teams to secure ongoing system reliability.
6. Cross-Functional Collaboration
- Work in partnership with engineering, facilities, quality, and validation teams to ensure effective project delivery.
- Coordinate with vendors and contractors during equipment installation and qualification.
- Support internal and external audits and inspections.
7. Training
- Provide training to facility personnel on validation processes and best practices.
