Validation Specialist

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Commissioning and Qualification Specialist – Utilities and Facilities

Position Summary

The Commissioning and Qualification (C&Q) Specialist 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), cleanrooms, compressed gases, and other support utilities. The C&Q Specialist ensures compliance with industry standards and regulatory requirements while working closely with cross-functional teams to support new installations, system upgrades, and operational readiness.

Key Responsibilities:

1. Commissioning Activities

2. Plan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed air) and facilities (e.g., cleanrooms, environmental monitoring systems).

3. Conduct FAT, SAT, and pre-qualification tests to verify system functionality.

4. Troubleshoot and resolve technical issues during the commissioning phase.

5. Qualification & Validation

6. Author, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.

7. Validate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.
8. Ensure systems meet performance requirements and GMP standards.

9. Perform thermal mapping, pressure testing, and other critical tests as needed.

10. Documentation

11. Develop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.

12. Document deviations, CAPAs, and change controls associated with facilities and utilities systems.

13. Ensure traceability of qualification activities in alignment with the Validation Master Plan (VMP).

14. Compliance and Risk Management

15. Ensure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).

16. Perform risk assessments and develop mitigation strategies for utility and facility systems.

17. Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.

18. Lifecycle Management

19. Oversee requalification and periodic review of utilities and facilities systems.

20. Manage system upgrades, decommissioning, and retrofits while ensuring GMP compliance.

21. Collaborate with engineering and maintenance teams to ensure ongoing system reliability.

22. Cross-Functional Collaboration

23. Partner with engineering, facilities, quality, and validation teams to ensure successful project execution.

24. Coordinate with vendors and contractors during equipment installation and qualification.

25. Provide support during internal and external audits and inspections.

26. Training

27. Train facility and maintenance personnel on the operation and maintenance of qualified utilities and facilities.

Qualifications:

Education

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or a related technical field.

Experience

• 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, compressed air, and cleanrooms.
• Kneat experience
• Familiarity with environmental monitoring and building management systems (BMS).

Skills

• Strong technical writing skills for protocol and report development.
• Proficient in using calibration and validation tools (e.g., thermal mappers, particle counters, flow meters).
• Excellent organizational and project management skills.
• Effective communication and troubleshooting abilities.

Knowledge

• In-depth knowledge of GMP, USP, ISPE, and ISO standards related to utilities and facilities.
• Familiarity with validation guidelines (e.g., ICH Q9, ASTM E2500).
• Understanding of cleanroom classification and monitoring (ISO , EU GMP Annex 1).

Preferred Qualifications

• Certification in validation or engineering disciplines (e.g., ISPE, ASHRAE).
• Experience with utilities automation systems (e.g., SCADA, PLCs).
• Knowledge of energy efficiency principles and sustainability practices for facility systems.

Working Conditions

• Manufacturing plant and utility environments, including cleanrooms.
• Occasional travel for vendor FATs or external inspections.
• Flexibility to work extended hours or weekends during critical project phases.