ATL03-062425 CQV Engineer - Facility Systems and Utilities (PA)
Validation & Engineering Group
Spring House, PA, USA
6/14/2022
Manufacturing
Full Time
Job Description
Job Description
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other technical services.
We are currently seeking a CQV Engineer with expertise in facility systems and clean utilities to support commissioning and qualification efforts for a new GMP manufacturing facility. The selected candidate must be available to work in cleanroom, mechanical, and construction areas, complying with project-specific safety and gowning requirements.
Location: Spring House, PA
Responsibilities:
- Author, review, and execute IQ and OQ protocols for critical GMP facility systems, including:
- Cleanroom HVAC systems (AHUs, exhaust fans, humidifiers)
- Clean utility systems (RO/DI, clean steam, compressed gases, chilled water)
- Building Management Systems (BMS), Environmental Monitoring Systems (EMS)
- Infrastructure systems: fire protection, alarms, and ETOP networks (Voice/Data/Security)
- Perform system walkthroughs, impact assessments, and develop traceability matrices.
- Coordinate with facility engineering and automation to ensure timely commissioning and start-up.
- Participate in deviation management, protocol execution, and documentation handover.
- Ensure all CQV activities comply with GDP and are aligned with regulatory and internal standards.
Qualifications:
- Bachelor’s degree in engineering, science, or related field.
- 5+ years of CQV experience in facility or utility system qualification in GMP settings.
- Strong understanding of cleanroom classifications, environmental controls, and utility distribution.
- Familiarity with automated systems and building infrastructure qualification requirements.
- Excellent communication and organizational skills.