CSV Engineer

Simotechnology; Cork; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

SimoTech in Co. Cork, Ireland seeks an experienced CSV Engineer to validate GMP computerised systems and equipment. The role focuses on lifecycle validation, IQ/OQ/PQ execution, change control, data integrity, and regulatory readiness, with a hybrid work setup requiring at least 3 days onsite weekly.

You will collaborate with automation, IT, QA and operations to ensure compliant system integration, prepare documentation, and support audits and inspections for a leading biopharma client.

Qualifications

• Bachelor-level degree in engineering, computer science or life sciences.
• Minimum 5 years’ experience in Life Sciences CSV roles.
• Technical experience with MES, PLC, SCADA or related automation systems is advantageous.
• Proven CSV lifecycle experience for GMP computerised systems and equipment.
• Strong knowledge of GAMP 5, data integrity, and 21 CFR Part 11/Annex 11 compliance.
• Experience executing IQ/OQ/PQ/UAT and preparing supporting documentation.
• Involvement with change control, deviation and CAPA management processes.
• Experience with periodic evaluations to maintain a validated state.
• Excellent attention to detail and cross-functional collaboration across tech and QA.

Responsibilities

• Perform full lifecycle CSV for GMP systems, from planning to 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 business and compliance needs.
• Execute and document Periodic Reviews to maintain validated state.
• Support and review change controls, deviations, and CAPA management processes.
• Collaborate with automation, IT, QA, and operations to ensure compliant system integration.
• Maintain awareness of data integrity and adhere to GAMP 5 and regulatory standards.
• Participate in regulatory inspections and support validation evidence readiness.

Skills

CSV lifecycle

IQ/OQ/PQ

UAT

Data integrity

GAMP 5

Regulatory compliance

CAPA management

Audit readiness

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering/Computer Science/Life Sciences

Tools

MES

PLC

SCADA

Job description

What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust and excellence,we play a critical partnering role to our clients’ life-changing supply ofproducts to patients. In return, there is excellent salary, benefits, careerprogression, educational support and much more.

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

This role involves hands-on lifecyclevalidation, ensuring systems are implemented, maintained, and operated inaccordance with regulatory requirements and GAMP 5 best practices. You willplay a key role in executing and reviewing validation deliverables, supportingdata integrity compliance, and maintaining validated systems through periodicreviews and change control activities. This is a hybrid work setup minimum 3days onsite per week.

KeyResponsibilities

• 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 ValidationPlans, Risk Assessments, Protocols, Reports, and Traceability Matrices.
  
• Conduct and support User Acceptance Testing (UAT), ensuring systemfunctionality meets intended business and compliance needs.
  
• Execute and document Periodic Reviews to maintain systems in a validatedstate.
  
• Support and review change controls, deviations, and CAPAs, ensuringalignment with data integrity and validation requirements.
  
• Collaborate closely with automation, IT, QA, and operations teams toensure compliant system integration and support.
  
• Maintain awareness of global data integrity principles and ensureadherence to GAMP 5 and regulatory standards.
  
• Participate in regulatory inspections and support validation evidencereadiness.
  

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 relatedautomation systems advantageous.
  
• Proven experience in CSV lifecycle activities for GMP computerisedsystems 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 supportingdocumentation.
  
• Practical involvement with change control, deviation, and CAPAmanagement processes.
  
• Experience performing or reviewing periodic evaluations to ensurevalidated state is maintained.
  
• Excellent attention to detail and ability to work collaboratively acrosstechnical 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 infrastructurequalification or OT/IT systems within GMP.
  
• Understanding of audit trail review, data retention, and access controlprinciples supporting data integrity.
  
• Experience supporting audit readiness and responding tovalidation-related queries.
  

What SimoTech CanOffer

• Role provides a high degree of autonomy to allow the successfulcandidate to reach their full potential.
  
• Develop new skills and enhance technical ability by working withinnovative technologies in a multi-disciplined environment.
  
• Opportunity to work with large corporate clients on exciting capitalprojects.