CSV Validation Engineer

About the Role

CREGG seeks an experienced CSV Validation Engineer to join a pharmaceutical client based in the Waterford Metropolitan Area. This role is a contract position for 12 months or more and requires onsite presence four days a week. Reporting directly to the Quality Manager for Validation and working alongside the Principal Validation Engineer, the candidate will collaborate with IT, OT, Operations, and Engineering teams to lead and support various validation tasks.

Key Responsibilities

• Create, assess, and carry out Computer System Validation (CSV) plans, protocols, and reports in compliance with GAMP 5 standards and regulatory mandates.
• Enforce uniform interpretation and application of the company’s validation policies across all computer systems aligned with Life Science standards.
• Manage Validation Master Plans, internal policies, and project timelines.
• Engage in cross-departmental groups to set validation strategies and goals for new systems, upgrades, and enhancements.
• Maintain up-to-date knowledge on validation guidelines, industry regulations, and provide insights for process improvements to management and project teams.
• Review current validation methods and emerging trends to identify improvement opportunities and lead initiatives accordingly.
• Oversee change control procedures for validated systems and lead risk mitigation including FMEA and risk evaluations for system modifications.
• Execute Change Control activities in alignment with quality standards and internal processes.
• Support computer system validation activities during internal and external audits, ensuring all validation documentation remains audit-ready.
• Track progress on validation projects against schedules and communicate updates to stakeholders regularly.
• Conduct Root Cause Analysis on quality or validation issues and implement corrective and preventive actions (CAPA).
• Report critical quality concerns promptly to management and aid in resolving them.
• Comply strictly with Environmental Health & Safety guidelines and Quality procedures.
• Perform additional responsibilities as assigned.

Requirements and Experience

• At least five years of experience in implementing IT solutions, integrating systems, supporting, and validating IT applications and interfaces within pharmaceutical, medical devices, or related regulated sectors.
• Expertise with system platforms, especially MES technologies such as Siemens and Rockwell.
• Comprehensive knowledge of regulatory frameworks including 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Strong understanding of Data Integrity principles.
• Capability in planning validation, capturing requirements, documentation design, system configuration, system testing, and troubleshooting.
• Excellent communication skills, able to engage effectively with cross-functional stakeholders at all levels.
• Possession of a valid Irish work permit is mandatory.