Validation Engineer II

Roles & Responsibilities

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

Education & 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, gases, and cleanrooms.
• Familiarity with environmental monitoring and building management systems.
• Familiarity with manufacturing plant and utility environments, including cleanrooms.
• Flexibility to work extended hours or weekends during critical project phases.