Senior Validation Specialist - Utilities and Facilities

Job Description

• Senior Validation Specialist – Utilities and Facilities

Position Summary

The Senior 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.

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).

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.

Qualifications

Education

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

Experience

• Minimum 8 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)

• 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.