Computer System Validation Engineer
A unique opportunity to join our company at an exciting time in its journey, where you can make a real impact and be proud of being part of our team.
Key Responsibilities:
* Manage computer system validation (CSV) automation change controls and non-conformances.
* Participate in the review of CSV procedures and protocols.
* Ensure compliance with CSV, Annex 11, and experience with ERP in a GMP manufacturing environment.
Day-to-Day Activities:
* Prepare and review validation documentation related to projects and change controls.
* Execute validation activities and protocols on affected systems.
* Manage computer system/automation-related change controls and other compliance-related tasks.
* Participate in the creation and review of existing and new CSV procedures and policies.
* Analyze test results and determine acceptability against predetermined criteria.
* Investigate and troubleshoot problems, determining solutions or recommendations for changes and/or improvements.
* Audit internal projects against internal validation policies and procedures.
* Coordinate the review and approval of specifications associated with computerized systems.
* Review and approve vendor validation documentation.
* Participate in regulatory audits and communicate company computer validation policies.
* Support the Quality Approval of Vendors and Suppliers of GxP computer systems.
* Assess company computer systems and identify/address potential 21CFR Part 11 or EU Annex 11 gaps.
* Manage projects and prepare status reports using Microsoft Project and other communication tools.
* Support local IT and Global IT on maintenance and testing of physical network infrastructure and security.
Qualifications, Experience, and Skills:
* Third-level degree in Science, Engineering, or Computer Science.
* 3+ years of related experience within the fields of Automation and Computer Systems and IT Infrastructure Qualification/validation.