Job Description

Department: Field - LL Location: Juncos, 077
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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.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Commissioning and Qualification Specialist – Utilities and Facilities

    • Position Summary

    The Commissioning and Qualification (C&Q) 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 C&Q 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.

    • Qualifications:

    Education

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

    • 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, compressed air, and cleanrooms.
  • Familiarity with environmental monitoring and building management systems (BMS).

    • 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).

    • Preferred Qualifications

  • 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.

    • 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.
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