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Validation Specialist (Utilities and Facilities) LL01-250903 Position in Matamoros - Validation & Engineering Group


Job 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.

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

  • Validation Specialist – Utilities and Facilities

Position Summary

The 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.

  1. 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.

  1. 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).

  1. 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.

  1. 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.

  1. 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.

  1. 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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Required Skill Profession

Ingeniería De Calidad


  • Job Details

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Unlock Your Validation Specialist Potential: Insight & Career Growth Guide


Real-time Validation Specialist Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Validation Specialist in Matamoros, Mexico, highlighting market share and opportunities for professionals in Validation Specialist roles.

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The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Validation & Engineering Group adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying Mexico laws and regulations

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