CSV Engineer Opcenter

Computer System Validation (CSV) Engineer | MES & Digital Manufacturing

? Cork, Ireland
? Permanent Opportunity
? Life Sciences / Pharmaceutical Manufacturing

The Opportunity

We are seeking an experienced Computer System Validation (CSV) Engineer to join a growing validation and digital manufacturing team supporting the implementation, validation, and lifecycle management of Manufacturing Execution Systems (MES) within a highly regulated GMP environment.

This is an excellent opportunity for a validation professional with strong experience in MES platforms, computerized systems, and regulatory compliance to play a key role in major digital transformation initiatives.

Working closely with Quality, IT, OT, Engineering, and Operations teams, you will lead and support validation activities for critical manufacturing systems, ensuring compliance with regulatory requirements while enabling efficient and reliable production operations.

Key Responsibilities

• Author, review, and execute CSV documentation including:
  • Validation Plans
  • IQ/OQ Protocols
  • Test Scripts
  • Summary Reports
  • Traceability Matrices
• Support validation activities from system implementation through to business release.
• Lead and support validation of MES platforms and associated interfaces.
• Develop validation strategies in accordance with:
  • GAMP 5
  • 21 CFR Part 11
  • Annex 11
  • Data Integrity requirements
• Participate in requirements gathering, risk assessments, and system design reviews.
• Support change control activities for validated systems.
• Lead and facilitate:
  • Risk Assessments
  • FMEA Activities
  • Impact Assessments
• Investigate validation and quality issues using Root Cause Analysis methodologies.
• Support internal audits, customer audits, and regulatory inspections.
• Maintain systems in a validated state and ensure audit readiness at all times.
• Drive continuous improvement initiatives across validation and digital manufacturing processes.

Required Experience

• 5+ years’ experience in Computer System Validation within a regulated pharmaceutical, biotech, medical device, or life sciences environment.
• Proven experience validating MES and manufacturing-related systems.
• Strong understanding of:
  • GAMP 5
  • 21 CFR Part 11
  • Annex 11
  • Data Integrity
  • Risk-Based Validation
• Experience supporting:
  • System Implementations
  • Upgrades
  • Integrations
  • Change Controls
• Experience producing and reviewing validation documentation throughout the system lifecycle.
• Strong stakeholder management and cross-functional communication skills.

Desirable Experience

Experience working with one or more of the following:

• Siemens Opcenter
• AspenTech
• Rockwell Automation platforms
• MES Systems
• Manufacturing Applications
• System Integrations
• Digital Manufacturing Initiatives

Exposure to programming, configuration, testing, and troubleshooting of manufacturing systems would be highly advantageous.

Candidate Profile

• Degree qualified in Computer Science, Engineering, Automation, IT, or a related discipline.
• Strong attention to detail and documentation quality.
• Self-motivated and capable of managing multiple projects simultaneously.
• Excellent problem-solving and analytical skills.
• Collaborative approach with the ability to work effectively across Quality, Engineering, IT, and Operations teams.

Why Apply?

? Work on large-scale digital manufacturing and MES projects
? Join a highly regulated, technology-driven environment
? Strong career development opportunities
? Exposure to modern manufacturing technologies and validation best practices
? Be part of a collaborative team driving continuous improvement and compliance excellence

If you’re an experienced CSV Engineer looking to contribute to the future of digital manufacturing within a GMP-regulated environment, we’d love to hear from you.