CSV Engineer

CREGG is currently looking for a Lead CSV Validation Engineer for a Pharma client based in Cork on a 12-month+ contract. My client is looking for someone with Siemens OpCenter experience. This is a site-based role, 4 days per week

Computer System Validation (CSV) Engineer

Reporting to: Quality Manager – Validation / Principal Validation Engineer

The Computer System Validation (CSV) Engineer is responsible for the design, execution, and support of validation projects and strategies associated with the implementation of Manufacturing Execution Systems (MES) within the production environment.

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 for MES solutions, including Siemens OpCenter. 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.
• Execute and complete validation activities from software installation through to business release for site systems, including MES platforms Siemens OpCenter, in accordance with 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 5–8 years’ experience implementing IT solutions, systems integration, support, and validation of IT applications and interfaces within the pharmaceutical, medical device, or similar regulated industry.
• Proven experience supporting the validation of MES platforms, Siemens OpCenter, and Strong working knowledge of:
• 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.

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.