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:
- Validation Specialist – Utilities and Facilities
Position Summary
The Validation 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 Validation 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
- 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).
- Conduct FAT, SAT, and pre-qualification tests to verify system functionality.
- Troubleshoot and resolve technical issues during the commissioning phase.
2. Qualification & Validation
- 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.
3. Documentation
- 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).
4. Compliance and Risk Management
- 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.
5. Lifecycle Management
- Oversee requalification and periodic review of utilities and facilities systems.
- Manage system upgrades, decommissioning, and retrofits while ensuring GMP compliance.
- Collaborate with engineering and maintenance teams to ensure ongoing system reliability.
6. Cross-Functional Collaboration
- Partner with engineering, facilities, quality, and validation teams to ensure successful project execution.
- Coordinate with vendors and contractors during equipment installation and qualification.
- Provide support during internal and external audits and inspections.
7. Training
- 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.
- 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 14644-1, 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.
