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
Computer System Validation (CSV) Engineer
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
- Design documentation
- System configuration
- System testing
- Troubleshooting
Excellent written, verbal, presentation, and stakeholder communication skills, with proven ability to build strong cross-functional relationships.
