Job Title: Computer System Validation Engineer
W2 Only.
Duration: 12 Months
Location: Summit, NJ 07901? (Hybrid Role- 50% onsite minimum required)
Education: Bachelor's degree required
Manager needs hands on Computerized systems validation experience, also need configuration and trouble shooting experience.
Must Haves:
5+ years of Computer system validation experience
5+ years of experience in 21CFR P11 compliance regulations
Good understanding of Audit Trail
Experience on troubleshooting issues related to compute systems validation.
Experience working on deviations
Position Overview:
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. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Detailed job description available upon request.