Snr Validation Engineer
Newark Metro Area, NJ
The Computer Systems Validation Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers.
Knowledge, Skills & Abilities:
Strong working knowledge of MS Windows client and server technologies.
Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
Ability to work with the end user to identify and document User and Functional Requirements
Knowledge of pharmaceutical laboratory and manufacturing systems.
Strong computer skills in Microsoft Office Suite Word, Excel, Visio and Outlook, and the ability to learn
Education & Experience:
BS degree in Engineering / Computer Science or equivalent
Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV