Validation & Engineering Group, Inc. logoValidation & Engineering Group, Inc. logo

Computer Systems Validation Specialist

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Qualifications:Bachelor's Degree in Science or Engineering. At least 5 years of relevant experience within the pharmaceutical, medical device, or biotechnology industries. Hands-on experience in direct process and laboratory environments. Fluency in both English and Spanish with exceptional verbal communication skills. Proficient in MS Windows and Microsoft Office applications. Comprehensive understanding of cGxP regulations and their application in regulatory compliance. Experience in creating and executing Design Documentation (URS, DS), IQ, OQ, PQ, and CSV protocols, as well as managing deviations and generating reports. Knowledge of Software Development Life Cycle (SDLC), Risk Assessment, Data Integrity, Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT). Familiarity with Ellab Data Loggers, Star Oddi Sensors, Keyence Microscopes, Kaye Data Loggers, and X-Ray Bar Code Verifiers.

About the job

Join our esteemed team at Validation & Engineering Group, Inc. as a Computer Systems Validation Specialist, where we value integrity and excellence. In this pivotal role, you will support the validation of laboratory equipment within the pharmaceutical, medical device, and biotechnology sectors, ensuring compliance with the highest industry standards.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Inc. (V&EG) is a premier service provider dedicated to delivering innovative solutions across the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. Our expertise encompasses Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and various other specialized services.

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