{"schemaVersion":"jobsearcher.job.v1","id":"d71574a475b1c8f26804b34b","url":"https://jobsearcher.com/jobs/d71574a475b1c8f26804b34b","canonicalUrl":"https://jobsearcher.com/jobs/d71574a475b1c8f26804b34b","title":"Validation Engineer","description":"Company Description\n\nValidation & 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.\n\nJob Description\n\nSenior Validation Specialist – Utilities and Facilities\nPosition Summary\nThe 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.\nKey Responsibilities:\n1. Commissioning Activities\nPlan 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).\nConduct FAT, SAT, and pre-qualification tests to verify system functionality.\nTroubleshoot and resolve technical issues during the commissioning phase.\n2. Qualification & Validation\nAuthor, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.\nValidate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.\nEnsure systems meet performance requirements and GMP standards.\nPerform thermal mapping, pressure testing, and other critical tests as needed.\n3. Documentation\nDevelop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.\nDocument deviations, CAPAs, and change controls associated with facilities and utilities systems.\nEnsure traceability of qualification activities in alignment with the Validation Master Plan (VMP).\n4. Compliance and Risk Management\nEnsure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).\nPerform risk assessments and develop mitigation strategies for utility and facility systems.\nEnsure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.\n5. Lifecycle Management\nOversee requalification and periodic review of utilities and facilities systems.\nManage system upgrades, decommissioning, and retrofits while ensuring GMP compliance.\nCollaborate with engineering and maintenance teams to ensure ongoing system reliability.\n6. Cross-Functional Collaboration\nPartner with engineering, facilities, quality, and validation teams to ensure successful project execution.\nCoordinate with vendors and contractors during equipment installation and qualification.\nProvide support during internal and external audits and inspections.\n7. Training\nTrain facility and maintenance personnel on the operation and maintenance of qualified utilities and facilities.\nSkills\nStrong technical writing skills for protocol and report development.\nProficient in using calibration and validation tools (e.g., thermal mappers, particle counters, flow meters).\nExcellent organizational and project management skills.\nEffective communication and troubleshooting abilities.\nKnowledge\nIn-depth knowledge of GMP, USP, ISPE, and ISO standards related to utilities and facilities.\nFamiliarity with validation guidelines (e.g., ICH Q9, ASTM E2500).\nUnderstanding of cleanroom classification and monitoring (ISO 14644-1, EU GMP Annex 1).\nWorking Conditions\nManufacturing plant and utility environments, including cleanrooms.\nOccasional travel for vendor FATs or external inspections.\nFlexibility to work extended hours or weekends during critical project phases.\n\nQualifications\n\nEducation\nBachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or a related technical field.\nExperience\nMinimum 8 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.\nHands-on experience with systems such as HVAC, purified water, clean steam, compressed air, and cleanrooms.\nFamiliarity with environmental monitoring and building management systems (BMS)\nCertification in validation or engineering disciplines (e.g., ISPE, ASHRAE).\nExperience with utilities automation systems (e.g., SCADA, PLCs).\nKnowledge of energy efficiency principles and sustainability practices for facility systems.\n\nAdditional Information\n\nAll your information will be kept confidential according to EEO guidelines.","company":"Validation","rawCompany":"validation","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:18:40.939Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-3028.00","title":"Calibration Technologists and Technicians","slug":"calibration-technologists-and-technicians"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Company Description\n\nValidation & 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.\n\nJob Description\n\nSenior Validation Specialist – Utilities and Facilities\nPosition Summary\nThe 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.\nKey Responsibilities:\n1. Commissioning Activities\nPlan 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).\nConduct FAT, SAT, and pre-qualification tests to verify system functionality.\nTroubleshoot and resolve technical issues during the commissioning phase.\n2. Qualification & Validation\nAuthor, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.\nValidate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.\nEnsure systems meet performance requirements and GMP standards.\nPerform thermal mapping, pressure testing, and other critical tests as needed.\n3. Documentation\nDevelop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.\nDocument deviations, CAPAs, and change controls associated with facilities and utilities systems.\nEnsure traceability of qualification activities in alignment with the Validation Master Plan (VMP).\n4. Compliance and Risk Management\nEnsure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).\nPerform risk assessments and develop mitigation strategies for utility and facility systems.\nEnsure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.\n5. Lifecycle Management\nOversee requalification and periodic review of utilities and facilities systems.\nManage system upgrades, decommissioning, and retrofits while ensuring GMP compliance.\nCollaborate with engineering and maintenance teams to ensure ongoing system reliability.\n6. Cross-Functional Collaboration\nPartner with engineering, facilities, quality, and validation teams to ensure successful project execution.\nCoordinate with vendors and contractors during equipment installation and qualification.\nProvide support during internal and external audits and inspections.\n7. Training\nTrain facility and maintenance personnel on the operation and maintenance of qualified utilities and facilities.\nSkills\nStrong technical writing skills for protocol and report development.\nProficient in using calibration and validation tools (e.g., thermal mappers, particle counters, flow meters).\nExcellent organizational and project management skills.\nEffective communication and troubleshooting abilities.\nKnowledge\nIn-depth knowledge of GMP, USP, ISPE, and ISO standards related to utilities and facilities.\nFamiliarity with validation guidelines (e.g., ICH Q9, ASTM E2500).\nUnderstanding of cleanroom classification and monitoring (ISO 14644-1, EU GMP Annex 1).\nWorking Conditions\nManufacturing plant and utility environments, including cleanrooms.\nOccasional travel for vendor FATs or external inspections.\nFlexibility to work extended hours or weekends during critical project phases.\n\nQualifications\n\nEducation\nBachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or a related technical field.\nExperience\nMinimum 8 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.\nHands-on experience with systems such as HVAC, purified water, clean steam, compressed air, and cleanrooms.\nFamiliarity with environmental monitoring and building management systems (BMS)\nCertification in validation or engineering disciplines (e.g., ISPE, ASHRAE).\nExperience with utilities automation systems (e.g., SCADA, PLCs).\nKnowledge of energy efficiency principles and sustainability practices for facility systems.\n\nAdditional Information\n\nAll your information will be kept confidential according to EEO guidelines.","datePosted":"2026-04-14T10:18:40.939Z","dateModified":"2026-04-14T10:18:40.939Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"d71574a475b1c8f26804b34b"},"url":"https://jobsearcher.com/jobs/d71574a475b1c8f26804b34b"}}