Lab IT CSV Engineer 1607

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.

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• 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.
  

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• 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.
  

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• Roleprovides a high degree of autonomy to allow the successfulcandidate to reach their full potential. xcfaprz
  
• Developnew skills and enhance technical ability by working withinnovative technologies in a multi- disciplined environment.
  
• Opportunityto work with large corporate clients