Lead CSV Validation Engineer - Pharma

CREGG; Waterford; On-site; EUR 70,000 - 110,000; Full time

Job summary

CREGG is seeking a Lead CSV Validation Engineer for a pharma client in Waterford on a 12-month+ contract. This site-based role (4 days per week) reports to Quality Manager – Validation / Principal Validation Engineer and focuses on delivering compliant, efficient CSV solutions.

The role requires leading validation activities within IT, OT, Operations and Engineering, ensuring quality, safety, and continuous improvement, while maintaining strong cross-functional collaboration.

Qualifications

• Minimum of 5 years’ experience implementing IT solutions, systems integration, support, and validation in regulated environments.

Responsibilities

• Author, review, and execute CSV plans, protocols, and reports per GAMP 5 and regulatory requirements.
• Ensure consistent interpretation of validation policies across computer systems.
• Lead validation strategies, risk assessments, and CAPA activities for new systems and upgrades.
• Support audits and maintain audit-ready validation documentation.

Skills

CSV Validation

Validation planning

Regulatory compliance

Root cause analysis

Tools

MES Platforms

Siemens

Rockwell

Job description

CREGG is seeking a Lead CSV Validation Engineer for a pharma client in Waterford on a 12-month+ contract. This site-based role (4 days per week) reports to Quality Manager – Validation / Principal Validation Engineer and focuses on delivering compliant, efficient CSV solutions.

The role requires leading validation activities within IT, OT, Operations and Engineering, ensuring quality, safety, and continuous improvement, while maintaining strong cross-functional collaboration.