Computer System Validation Engineer
This is a unique opportunity to make a real impact and be part of a company's journey from start-up to ramp-up. We are seeking an experienced Computer System Validation (CSV) engineer with circa 3 years of experience in CSV, who can manage automation change controls, ensure compliance for Annex 11, and have experience with ERP in a GMP manufacturing environment.
Key Responsibilities:
* Prepare and review validation documentation, including risk assessments, traceability matrices, 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/or improvements.
Requirements:
* Bachelor's degree in Science, Engineering, or Computer Science.
* Minimum 3+ years of related experience in Automation and Computer Systems, IT Infrastructure, and Qualification/validation.
Desirable Skills:
* Experience with managing CSV automation change controls and non-conformances.
* Participation in reviews of CSV procedures and protocols.
* Familiarity with ERP in a GMP manufacturing environment.
Please note that relevant experience may substitute for education. If you are looking to join a company at its early stages and contribute to its growth, this could be the perfect role for you.