Sr. Computer System Validation (CSV) Engineer

Senior Computer System Validation (CSV) Engineer

Location: Limerick,
Ireland
Job Type: Full -Time
Experience: 10+ Years
Eligibility: EU Nationals Preferred

Role Overview

We are seeking an experienced Senior CSV Lead to
manage validation and compliance activities for GxP -regulated computerized
systems within a pharmaceutical manufacturing environment. The role requires
strong expertise in Computer System Validation (CSV), Software Validation,
IQ/OQ/PQ execution, Data Integrity, and regulatory compliance.

The successful candidate will lead validation
lifecycle activities for manufacturing, laboratory, automation, and enterprise
systems while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5,
and Data Integrity requirements.

Key Responsibilities

• Lead end -to -end CSV lifecycle
  activities for GxP systems.
  
• Develop and execute IQ/OQ/PQ
  protocols and validation documentation.
  
• Review and approve URS, Risk
  Assessments, Traceability Matrices, and Validation Summary Reports.
  
• Support validation of MES, LIMS,
  SCADA, ERP, laboratory, and manufacturing systems.
  
• Ensure compliance with GAMP 5, 21 CFR
  Part 11, EU Annex 11, and ALCOA+ principles.
  
• Manage change controls, deviations,
  CAPAs, and periodic reviews.
  
• Support audits and regulatory
  inspections.
  
• Collaborate with QA, IT, Engineering,
  Manufacturing, and Automation teams.
  
• Mentor junior validation engineers
  and support site projects.
  

Required Qualifications

• Bachelor’s degree in Engineering,
  Computer Science, Life Sciences, or related field.
  
• 10+ years of CSV experience in
  pharmaceutical or biotech manufacturing.
  
• Strong expertise in:
  
• Computer System Validation (CSV)
  
• Software Validation
  
• IQ/OQ/PQ
  
• Data Integrity
  
• GxP Compliance
  
• Hands -on experience with regulated
  manufacturing and laboratory systems.
  
• Strong knowledge of FDA 21 CFR Part
  11, EU Annex 11, and GAMP 5.
  

Preferred

• Experience with MES, SCADA, LIMS,
  SAP, DeltaV, or similar GxP platforms.
  
• Exposure to cloud/SaaS validation and
  automation systems.
  
• ISPE, ASQ, PMP, or CSV -related
  certifications preferred.