Computer System Validation Engineer
This is a unique opportunity to join the company during its growth phase and make a significant impact on its journey.
* Participate in reviews of CSV procedures and protocols.
* E nsure compliance with Annex 11 and Good Manufacturing Practice (GMP).
* Experience with Enterprise Resource Planning (ERP) systems in a GMP manufacturing environment is highly desirable.
Day-to-Day Activities:
* Prepare and review validation documentation, including risk assessments and validation reports.
* Execute validation activities and protocols on affected systems.
* Manage computer system/automation-related change controls and other compliance 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 improvements.
* Audit internal projects against internal validation policies and procedures.
* Review and approve vendor validation documentation.
* Participate in regulatory audits and communicate the company's computer validation policies.
* Support 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:
* Requires a third-level degree in Science, Engineering, or Computer Science with 3+ years of related experience in Automation and Computer systems and IT Infrastructure Qualification/validation. Relevant experience may substitute for education.