Kinsale, Co. Cork, Ireland | Posted on 25/09/2025
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 productsto patients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.
SimoTech has a new opportunity for an engineerwith 3+ years’ experience in Computer Systems Validation and Laboratory IT systemsto join our team. The successful candidate will work as part of our client’s ComputerisedInstruments team, supporting a variety of computerised instrument systemsacross laboratory and manufacturing operations at their state-of-the-artpharmaceutical manufacturing facility in Cork. The role has a hybrid workingmodel.
The ideal candidate will have a minimum of 3 years’experience in a similar role within a GMP / GxP environment, ensuringcomputerised instrument systems meet all data integrity, cyber security,quality, lifecycle management and regulatory requirements.
Key Responsibilities
Manageand coordinate the Lab System CSV deliverables for new and existing projectsfrom initiation to release, prioritising support activities in line withproject schedules.
Generatevalidation documentation in accordance with site procedures and regulatoryguidelines, including but not limited to, 21 CFR Part 11, EU GMP Annex 11, and dataintegrity guidelines.
Work closely with 3 rd parties to installcomputerised instrument solutions, ensuring correct configuration to successfullyintegrate with existing onsite IT services and infrastructure.
Initiate and implement Change Control activities inaccordance with quality standards and practices.
Followall relevant EHS procedures and assist in incident investigations as required.
Recognisethe importance of the quality control function in pharmaceuticalproduction.
Actively participate and contribute to teammeetings.
Qualifications & Experience
3+years’ experience supporting IT Applications including validating laboratory computerisedsystems, writing validation plans, requirements gathering, designdocumentation, system configuration, system testing and troubleshooting.
Experience implementingchanges for IT applications in a GMP environment.
Knowledge of 21 CFR Part 11and data integrity guidelines.
Experience with MS Office andsoftware installation knowledge.
Strong interpersonal andcommunication skills are required, with a proven ability to communicate and buildrelationships cross-functionally.
What SimoTech CanOffer
Roleprovides a high degree of autonomy to allow the successfulcandidate to reach their full potential.
Developnew skills and enhance technical ability by working withinnovative technologies in a multi- disciplined environment.
Opportunityto work with large corporate clients
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