Job description
Why Simo. Tech What is it like to work at Simo. Tech? With a strong collaborative teamwork culture based on respect, trust, and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more.
Audit Trail Validation Engineer 1647 Simo. Tech has an exciting opportunity for an Audit Trail Validation Engineer to join our team. In this role, you will support our client’s Audit Trail team, working across a range of IT applications within their state‑of‑the‑art laboratory facility in Cork. This position offers a hybrid working model.
The successful candidate will contribute to the validation of complex audit trail configurations, ensuring systems meet stringent ALCOA+ and regulatory expectations. Become part of a team committed to excellence in CSV delivery across a cutting‑edge lab environment.
Key Responsibilities
Review audit trails across all laboratory IT systems, assessing user activity, system changes, and compliance with data integrity requirements. Log into each laboratory application to evaluate audit trail entries, determine the nature and impact of recorded changes, and escalate issues where required. Maintain and execute a quarterly audit trail review schedule, ensuring all instruments and lab systems are assessed in line with internal procedures and regulatory expectations.
Support laboratory informatics systems, system administration activities, and the upkeep of validated system configurations. Review vendor release notes and engage with system vendors to understand upcoming upgrades or new features, assessing their impact on validation status and data integrity; prepare summary assessment reports.
Support validation activities, including drafting and executing validation protocols, managing change controls, and maintaining IT/CSV documentation in compliance with 21 CFR Part 11, EU GMP Annex 11, and data integrity guidelines. Collaborate with internal and external partners to ensure laboratory IT systems remain compliant, secure, and aligned with site procedures and quality standards.
Follow all relevant EHS procedures and contribute to incident investigations when required. Actively participate in team meetings, sharing insights from audit trail reviews and contributing to continuous improvement initiatives.
Requirements
Qualifications & Experience Bachelor’s degree in Engineering, Computer Science, Automation, or a related technical discipline. Basic understanding of validation activities and familiarity with laboratory IT applications. Ability to follow established procedures when implementing changes to IT applications in a GMP or regulated environment.
General awareness of pharmaceutical regulatory requirements, including data integrity principles and good documentation practices. Proficiency with MS Office, with the capability to follow software setup or configuration instructions. Strong attention to detail and good analytical/problem‑solving skills. Effective communication and teamwork skills, with the willingness to collaborate across IT, QA, and laboratory teams.
This role is also open to recent graduates who have a strong interest in validation and have completed an internship in this area.
Benefits
What Simo. Tech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Develop new skills and enhance technical ability by working with innovative technologies in a multi- disciplined environment. Opportunity to work with large corporate clients