Intermediate Lab CSV IT Engineer 1706

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 is seeking an IntermediateLab IT CSV Engineer to support our biopharma client in Co. Cork Working closelywith the project team, you will support the planning and delivery of validationactivities across a range of systems and business initiatives.

This role involves contributing tovalidation documentation, ensuring compliance with relevant quality andregulatory standards, and working with stakeholders to maintain validated andcompliant system environments.

• Support the execution of CSV deliverables for laboratory computerisedsystems throughout their lifecycle.
  
• Assist with equipment categorisation, risk assessments, and validationplanning activities.
  
• Generate, review, and execute validation documentation, includingprotocols and reports, in accordance with regulatory and site requirements.
  
• Support the implementation and validation of system upgrades,enhancements, and change controls.
  
• Assist with the integration of laboratory systems into the wider ITinfrastructure while maintaining compliance standards.
  
• Participate in deviation investigations and help ensure issues aredocumented and resolved appropriately.
  
• Collaborate with QA, IT, business users, and vendors to deliver projectmilestones and maintain validated system states.
  
• Support audit readiness activities by maintaining accurate validationand traceability documentation.
  
• Troubleshoot system and validation-related issues and contribute tocontinuous improvement initiatives.
  
• Adhere to EHS and Quality requirements and actively contribute to teamobjectives.
  

• Bachelor's degree inEngineering, Computer Science, or a related technical discipline.
  
• Minimum 3-5 years'experience in Computer System Validation within a regulated pharmaceutical,biotechnology, or laboratory environment.
  
• Working knowledge ofGxP systems, 21 CFR Part 11, Data Integrity principles, and validation bestpractices.
  
• Experience supportingvalidation activities for laboratory computerised systems and generating SDLCdocumentation.
  
• Familiarity with systemupgrades, change control processes, and risk-based validation approaches.
  
• Understanding oflaboratory system integrations and interactions with enterprise ITinfrastructure.
  
• Proficiency withMicrosoft Office applications and general software configuration andtroubleshooting.
  
• Strong communication and stakeholder engagementskills, with the ability to work effectively within cross-functional teams.
  

• 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