CSV/ Validation Engineer

Job Description:        

• 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.