Computer Systems Validation Engineer
Summary:
The Computer Systems Validation Engineer ensures that computerized systems—including process automation, IT infrastructure, and enterprise applications—comply with regulatory and company quality standards. This role drives validation activities, documentation, and change management across GMP environments.
Responsibilities:
- Prepare and review validation documentation for projects and change controls.
- Manage change controls, non-conformances, and other compliance-related activities.
- Review and improve Computer System Validation (CSV) policies and procedures.
- Analyze test results and assess compliance against acceptance criteria.
- Investigate issues, determine root causes, and recommend corrective actions.
- Identify and implement procedures to maintain compliance with regulatory standards (e.g., Part 11, Annex 11).
- Coordinate validation activities with cross-functional teams and external vendors.
- Support regulatory audits and communicate company validation policies.
- Manage validation projects and prepare progress/status reports using Microsoft Project or similar tools.
Requirements:
- Bachelor’s degree in Engineering, Chemistry, Life Sciences, or equivalent experience (advanced experience may substitute for degree).
- Minimum 5 years of experience in Automation, Computer Systems, or IT Infrastructure Qualification/Validation.
- Strong background in GMP environments required.
- Hands-on experience with systems such as DeltaV and Maximo is highly desirable.
- Solid understanding of regulatory compliance (FDA 21 CFR Part 11, EU Annex 11).
- Excellent documentation, analytical, and project management skills.
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