Computer Systems Validation Engineer
We are seeking a highly skilled and experienced Computer Systems Validation Engineer to join our team.
The ideal candidate will have a strong background in computer systems validation, with experience working in GMP environments. They will be responsible for ensuring that computerized systems comply with regulatory and company quality standards.
Main 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 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.