Lead CSV Validation Engineer – Pharma (Cork)

About the role

We are seeking a Lead CSV Validation Engineer to join a pharmaceutical client in Cork on a 12‑month+ contract. Reporting to the Quality Manager – Validation, you will lead the validation of Manufacturing Execution Systems, primarily Siemens OpCenter, ensuring regulatory compliance and robust system performance.

Key responsibilities

• Author, review and execute Computer System Validation (CSV) plans, protocols and reports in line with GAMP 5 and regulatory requirements.
• Execute validation activities from software installation through to business release for MES platforms, especially Siemens OpCenter.
• Lead cross‑functional teams to define validation strategies for new systems, enhancements and upgrades.
• Maintain up‑to‑date knowledge of validation standards, industry regulations and provide recommendations to project teams.
• Drive continuous improvement by reviewing validation practices and emerging trends.
• Manage change control processes, conduct risk assessments (FMEA) and ensure mitigation activities are documented.
• Support CSV activities during internal, customer and regulatory audits, keeping documentation audit‑ready.
• Monitor project progress, report status to stakeholders and ensure timelines are met.
• Investigate quality and validation issues using Root Cause Analysis and implement CAPA.

Required profile

• Proven experience in Computer System Validation within a pharmaceutical or life‑science environment.
• Hands‑on experience with Siemens OpCenter and other MES solutions.
• Strong knowledge of GAMP 5 guidelines and regulatory expectations.
• Ability to lead validation projects and work effectively with IT, OT, Operations and Engineering teams.
• Experience with change control, risk assessment (FMEA) and CAPA processes.
• Excellent documentation skills and audit support experience.

Required skills

• Siemens OpCenter
• GAMP 5
• Manufacturing Execution Systems (MES)
• Computer System Validation (CSV)
• FMEA
• Risk assessment
• Root Cause Analysis
• CAPA
• Change Control