Computer Systems Validation Engineer
Location: Limerick, County Limerick
About the company:
Innopharma Technical Services, part of Innopharma Group, specializes in the training and employment of highly skilled, project ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.
Are you ready to take the next step in your career within a leading biopharma environment?
We are now seeking a Computer Systems Validation Engineer to join our team to provide support in validation/qualification activities to our Multinational Manufacturing client based in Co. Limerick.
About the position:
This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Key responsibilities:
- Prepares and reviews validation documentation for projects and change controls.
- Manages change controls, non-conformances, and other compliance-related tasks.
- Reviews and contributes to current and future CSV procedures and policies.
- Analyses test results against acceptance criteria to determine compliance.
- Investigates, troubleshoots, and recommends solutions or improvements.
- Identifies current and future compliance requirements and proposes methods for implementing and maintaining necessary procedures, actions, and documentation.
- Coordinates validation activities with internal departments and external vendors/contractors.
- Supports regulatory audits and communicates company computer validation policies.
- Assesses computer systems for Part 11 and Annex 11 compliance gaps.
- Manages projects and prepares progress reports using Microsoft Project and other tools.
- Supervises, leads, or manages junior personnel as required.
Preferred Experience:
- Minimum BS/BA in Engineering, Chemistry, or Life Sciences is required.
- 3+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation is desired; will substitute relevant experience for education.
- Experience in a GMP environment is essential.
- Strong technical writing and documentation skills.
- Excellent communication and collaboration skills.
- A proactive, detail-focused approach with a passion for continuous improvement.
Note:
- Due to the nature of the business, additional duties may be required from time to time.
- All applicants must be eligible to work in Ireland without sponsorship
If you have any questions, please reach out to: [email protected]
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