MES Engineer
Validation & Engineering GroupNorth Carolina, United States
Posted September 30, 2025
Full Time
About the Company
Validation & Engineering Group, Inc., established in 1997, offers comprehensive services to the pharmaceutical, medical device, and biotechnology industries. Specializing in validation, control system solutions, instrumentation, training, equipment rentals, and regulatory compliance, V&EG ensures adherence to global regulatory standards. With a focus on audit and assessment, automated process control, and project management, the company's agility, talent pool, and technical expertise make it a leading provider in the sector.
Job Description
Validation & Engineering Group, Inc. (V&EG) is seeking a Senior Computer System Validation (CSV) Specialist to support a biologics manufacturing facility. The role involves planning, executing, and reviewing validation deliverables according to FDA, EMA, ICH, and GAMP 5 guidelines. Collaboration with Quality, IT, Engineering, and Manufacturing teams is crucial for ensuring validated and compliant MES system operation.
Requirements
- Lead and execute CSV activities for MES (Syncade)
- Develop and maintain validation documentation
- Partner with Manufacturing and Quality teams
- Perform impact assessments and change control
- Ensure alignment with GAMP 5, 21 CFR Part 11, Annex 11, and other regulations
- Collaborate with IT and Engineering
- Provide audit support