Validation Engineer

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. - Senior Validation Specialist – Utilities and FacilitiesPosition 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. 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. All your information will be kept confidential according to EEO guidelines.