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 experience in either clean utility systems or automation/CSV to support commissioning and qualification activities for a major GMP manufacturing project. This role requires availability to work in production, packaging, and construction areas, following site safety, quality, and gowning requirements.

Location: Norwood, MA

Responsibilities:

• Prepare and execute commissioning and qualification (C&Q) protocols related to clean utilities and/or GMP automation systems.

• Systems may include:

  • Utilities: Clean Steam distribution, WFI storage and distribution, compressed air systems (compressors, dryers, dry receivers), process air distribution, and secondary lift stations.

  • Automation/CSV: Level 4 SCADA orchestration layer, continuous monitoring systems (CMS), process control systems (PCS), data historian systems (DHS), and related PLC-based platforms.

• Participate in FAT, SAT, Start-up, IOV, IOQ, and PQ activities as applicable to assigned systems.

• Support discrepancy resolution and ensure traceability to applicable URS and design documentation.

• Interface with Quality, Engineering, and Digital teams to ensure testing and documentation meet current site procedures and regulatory requirements.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related field.

• Minimum 5 years of CQV experience in either clean utility systems or automation/CSV systems for GMP manufacturing.

• Familiarity with GAMP5, 21 CFR Part 11, Annex 11, and data integrity principles.

• Strong documentation and protocol execution skills.

• Ability to work independently in dynamic construction and operational environments.

• Must be able to follow gowning, safety, and GMP procedures in classified and active areas.