Computer System Validation Engineer
Make a real impact and be proud of being part of our great company's journey.
Key Responsibilities:
* Manage CSV automation change controls and non-conformances.
* Review and contribute to CSV procedures and protocols.
* Ensure compliance for CSV, including Annex 11 experience.
* Utilize ERP in a GMP manufacturing environment.
Day-to-Day Responsibilities:
1. Prepare and review validation documentation, including risk assessments, traceability matrices, and validation reports.
2. Execute validation activities and protocols on affected systems.
3. Manage computer system/automation related change controls and other compliance-related tasks.
4. Participate in creating and reviewing existing and new CSV procedures and policies.
5. Analyze testing results and determine acceptability against predetermined criteria.
6. Investigate and troubleshoot problems, determining solutions or recommendations for changes and/or improvements.
7. Audit internal projects against internal validation policies and procedures.
8. Coordinate the review and approval of specifications associated with Computerised Systems.
9. Collaborate with global departments or outside contractors/vendors to complete validation tasks.
10. Review and approve vendor validation documentation.
11. Participate in regulatory audits and communicate computer validation policies.
12. Support Quality Approval of Vendors and Suppliers of GxP computer systems.
13. Assess company computer systems, identifying and addressing potential 21CFR Part 11 or EU Annex 11 gaps.
14. Manage projects and prepare status reports using Microsoft Project and other communication tools.
15. Support local IT and Global IT on maintenance and testing of physical network infrastructure and security.
Qualifications, Experience, and Skills:
Requires a third-level degree in Science, Engineering, or Computer Science with 3+ years of related experience within Automation and Computer systems and IT Infrastructure Qualification/validation. Relevant experience may substitute for education.