Validation Engineer

Validation & Engineering Group • Juncos, PR

106d

About The Position

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.

Requirements

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

Nice To Haves

• 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).

Responsibilities

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

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees