Computer Systems Validation Specialist

Company Description

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.

Job Description

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

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.

Additional Information

All your information will be kept confidential according to EEO guidelines.