CSV Engineer

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 currently looking for a Lead CSV Validation Engineer for a Pharma client based in Waterford on a 12-month+ contract. This is a site-based role, 4 days per week

Reporting to: Quality Manager – Validation / Principal Validation Engineer

The successful candidate will work as part of a cross-functional team comprising IT, OT, Operations, and Engineering functions to lead and support validation activities. The role focuses on delivering efficient, accurate, and regulatory-compliant systems that meet both internal and external quality requirements.

The CSV Engineer will perform all activities competently and efficiently, with due regard for safety, quality, continuous improvement, and fostering a positive team environment.

Key Responsibilities

• Author, review, and execute Computer System Validation (CSV) plans, protocols, and reports in alignment with GAMP 5 guidelines and applicable regulatory requirements.
• Ensure consistent interpretation and implementation of corporate validation policies across all computer system areas in line with the company's Life Science standards.
• Validation Master Plans, company policies, and project schedules.
• Participate in cross-functional teams to establish validation strategies and objectives supporting new systems, enhancements, and system upgrades.
• Maintain up-to-date knowledge of validation requirements, industry regulations, and guidance documents, providing updates and recommendations to management and project teams.
• Review validation practices and emerging industry trends, identify opportunities for continuous improvement, and lead improvement initiatives where appropriate.
• Ensure change control processes are followed for validated systems and lead risk mitigation activities, including FMEA and risk assessments for new systems and upgrades.
• Complete associated Change Control activities in accordance with quality standards and company procedures.
• Support CSV activities during internal audits, customer audits, and regulatory inspections while maintaining audit-ready validation documentation.
• Monitor validation project progress to ensure adherence to timelines and provide regular updates to stakeholders.
• Conduct thorough investigations into quality and validation issues using Root Cause Analysis methodologies and implement effective corrective and preventative actions (CAPA).
• Escalate critical quality issues to the appropriate level of management and support final resolution activities.
• Adhere to all Environmental Health & Safety (EHS) guidelines and Quality procedures.
• Perform additional duties as required.

Requirements & Experience

• Minimum of 5 years’ experience implementing IT solutions, systems integration, support, and validation of IT applications and interfaces within the pharmaceutical, medical device, or similar regulated industry.
• System Platform knowledge
• 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Data Integrity principles
• Proficiency with MES platforms and related technologies, including Siemens and/or Rockwell systems.
• A Valid Irish work permit

Demonstrated technical expertise in:

• Validation planning
• Requirements gathering
• System testing
• Troubleshooting

Excellent written, verbal, presentation, and stakeholder communication skills, with proven ability to build strong cross-functional relationships.