Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients’ life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.
SimoTech has an excitingopportunity for an Audit Trail Validation Engineer to join our team. In thisrole, you will support our client’s Audit Trail team, working across a range ofIT applications within their state‑of‑the‑art laboratory facility in Cork. Thisposition offers a hybrid working model.
The successful candidate will contributeto the validation of complex audit trail configurations, ensuring systems meetstringent ALCOA+ and regulatory expectations. Become part of a team committedto excellence in CSV delivery across a cutting ‑ edgelab environment.
Key Responsibilities
Reviewaudit trails across all laboratory IT systems, assessing user activity, systemchanges, and compliance with data integrity requirements.
Loginto each laboratory application to evaluate audit trail entries, determine thenature and impact of recorded changes, and elevate issues where required.
Maintainand execute a quarterly audit trail review schedule, ensuring all instrumentsand lab systems are assessed in line with internal procedures and regulatoryexpectations.
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.
Collaboratewith internal and external partners to ensure laboratory IT systems remaincompliant, secure, and aligned with site procedures and quality standards.
Follow all relevant EHS procedures and contribute to incident investigations when required.
Activelyparticipate in team meetings, sharing insights from audit trail reviews and contributing to continuous improvement initiatives.
Requirements
Qualifications & Experience
Bachelor’s degree inEngineering, Computer Science, Automation, or a related technical discipline.
Basic understanding ofvalidation activities and familiarity with laboratory IT applications.
Ability to follow establishedprocedures when implementing changes to IT applications in a GMP or regulatedenvironment.
General awareness ofpharmaceutical regulatory requirements, including data integrity principles andgood documentation practices.
Proficiency with MS Office,with the capability to follow software setup or configuration instructions.
Strong attention to detail andgood analytical/problem‑solving skills.
Effective communication andteamwork skills, with the willingness to collaborate across IT, QA, andlaboratory teams.
Role is also open to recent graduates who have a strong interest in validation and have completed an internship in this area.
What SimoTech Can Offer
Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
Opportunity towork with large corporate clients
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