CSV Engineer

Why SimoTech

What is it like to work at SimoTech? 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.

CSV Engineer 1744

SimoTech is seeking an experienced CSV Engineer to support the validation and compliance of GMP-computerised systems and equipment for a leading biopharma client based in Co. Cork.

This role involves hands-on lifecycle validation, ensuring systems are implemented, maintained, and operated in accordance with regulatory requirements and GAMP 5 best practices. You will play a key role in executing and reviewing validation deliverables, supporting data integrity compliance, and maintaining validated systems through periodic reviews and change control activities. This is a hybrid work setup minimum 3 days onsite per week.

Key Responsibilities

• Perform full lifecycle Computer System Validation (CSV) for GMP systems, from planning and risk assessment through IQ/OQ/PQ execution and reporting.
  
• Develop and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Reports, and Traceability Matrices.
  
• Conduct and support User Acceptance Testing (UAT), ensuring system functionality meets intended business and compliance needs.
  
• Execute and document Periodic Reviews to maintain systems in a validated state.
  
• Support and review change controls, deviations, and CAPAs, ensuring alignment with data integrity and validation requirements.
  
• Collaborate closely with automation, IT, QA, and operations teams to ensure compliant system integration and support.
  
• Maintain awareness of global data integrity principles and ensure adherence to GAMP 5 and regulatory standards.
  
• Participate in regulatory inspections and support validation evidence readiness.
  

Requirements

Key Requirements

• Bachelor’s Degree in Engineering, Computer Science, or Life Sciences.
  
• Minimum of 5 years’ experience in Life Sciences CSV roles.
  
• Technical or project experience with MES, PLC, SCADA, or related automation systems advantageous.
  
• Proven experience in CSV lifecycle activities for GMP computerised systems and laboratory or manufacturing equipment.
  
• Strong working knowledge of GAMP 5, data integrity, and 21 CFR Part 11 / Annex 11 compliance principles.
  
• Demonstrated experience executing IQ/OQ/PQ/UAT and preparing supporting documentation.
  
• Practical involvement with change control, deviation, and CAPA management processes.
  
• Experience performing or reviewing periodic evaluations to ensure validated state is maintained.
  
• Excellent attention to detail and ability to work collaboratively across technical and QA functions.
  
• Exposure to MES and/or manufacturing automation systems is desirable.
  
• Knowledge of manufacturing system integration including automation layer (PLC/DCS/MES) and associated data flows.
  
• Familiarity with regulated IT systems, including infrastructure qualification or OT/IT systems within GMP.
  
• Understanding of audit trail review, data retention, and access control principles supporting data integrity.
  
• Experience supporting audit readiness and responding to validation-related queries.
  

Benefits

What SimoTech 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 on exciting capital projects.