Computer Systems Validation Specialist
Validation & Engineering GroupOhio, United States
Posted September 17, 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 skilled Computer Systems Validation Specialist for the Lab equipment component. The role involves validating equipment performance under rigorous standards, utilizing cGxP and regulatory guidance, and ensuring compliance with industry best practices. Bilingualism in English and Spanish is required.
Requirements
- Bachelor's Degree in Science or Engineering
- Minimum of 5 years of experience in pharmaceutical, medical device or biotechnology industries
- Experience in direct process / laboratory areas
- Proficiency using MS Windows and Microsoft Office applications
- Strong knowledge in cGxP and regulatory guidance
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ, CSV protocols development and execution, deviations and reports generation
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT)
- Strong knowledge of Ellab Data Loggers, Star Oddi Sensors, Keyence Microscopes, Kaye Data Loggers, X-Ray, Bar Code Verifiers
- Experience with Kneat, CDOCS, Maximo
- Technical Writing skills
- Available to work extended hours