Computer Systems Validation Specialist Job at Validation & Engineering Group, New Albany, OH

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  • Validation & Engineering Group
  • New Albany, OH

Job Description

Job Description

Job Description

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.

Job Tags

Weekend work,

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