Validation & Engineering Group, Inc.
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Company Description
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. Job Title Senior Validation Specialist – Utilities and Facilities Overview
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. Responsibilities
Commissioning Activities: plan and execute commissioning 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. 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. Documentation: develop and maintain accurate documentation including protocols, validation reports, and SOPs; document deviations, CAPAs, and change controls with traceability in alignment with the Validation Master Plan (VMP). Compliance and Risk Management: ensure all qualification activities meet global regulatory requirements (FDA, EMA, WHO); perform risk assessments and develop mitigation strategies; ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards. Lifecycle Management: oversee requalification and periodic review of utilities and facilities systems; manage upgrades, decommissioning, and retrofits while ensuring GMP compliance; collaborate with engineering and maintenance teams for system reliability. Cross-Functional Collaboration: partner with engineering, facilities, quality, and validation teams; coordinate with vendors and contractors during installation and qualification; provide support during internal and external audits and inspections. Training: train facility and maintenance personnel on operation and maintenance of qualified utilities and facilities. Qualifications
Education
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or 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. 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. Additional Information
All your information will be kept confidential according to EEO guidelines. Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Get notified about new Validation Engineer jobs in
Juncos, Puerto Rico .
#J-18808-Ljbffr
(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. Job Title Senior Validation Specialist – Utilities and Facilities Overview
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. Responsibilities
Commissioning Activities: plan and execute commissioning 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. 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. Documentation: develop and maintain accurate documentation including protocols, validation reports, and SOPs; document deviations, CAPAs, and change controls with traceability in alignment with the Validation Master Plan (VMP). Compliance and Risk Management: ensure all qualification activities meet global regulatory requirements (FDA, EMA, WHO); perform risk assessments and develop mitigation strategies; ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards. Lifecycle Management: oversee requalification and periodic review of utilities and facilities systems; manage upgrades, decommissioning, and retrofits while ensuring GMP compliance; collaborate with engineering and maintenance teams for system reliability. Cross-Functional Collaboration: partner with engineering, facilities, quality, and validation teams; coordinate with vendors and contractors during installation and qualification; provide support during internal and external audits and inspections. Training: train facility and maintenance personnel on operation and maintenance of qualified utilities and facilities. Qualifications
Education
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or 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. 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. Additional Information
All your information will be kept confidential according to EEO guidelines. Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Get notified about new Validation Engineer jobs in
Juncos, Puerto Rico .
#J-18808-Ljbffr