CSV/ Validation Engineer
Summit, New Jersey
Posted on: July 13, 2021
Industry: Admin/Networking/System Engineer
Job Number: JN -072021-66930
- The CSV 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.
- The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation.
Knowledge, Skills & Abilities:
- Strong working knowledge of MS Windows client and server technologies.
- Working knowledge of standard networking principles and 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.
- Experience executing equipment qualification documents
- Ability to interact effectively with laboratory, QA, and Facilities groups
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.
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