CSV Validation Specialist (OH)

Validation & Engineering Group, Inc.

(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: * CSV Validation Specialist (Lab equipment) Qualifications: * Bachelor's Degree in Science or Engineering.

* Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.

* Experience in direct process / laboratory areas.

* Must be fully bilingual (English / Spanish) with excellent oral skills.

* Must be proficient using MS Windows and Microsoft Office applications.

* Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.

* 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 and investigations processes.

* Available to work extended hours, possibility of weekends and holidays.