We are seeking an experienced CSV Senior Consultant with a strong background in pharmaceutical automation systems to support multiple automation upgrade projects at our Cork manufacturing site. The consultant will play a critical role in ensuring compliant validation of upgraded HMI and PLC systems in a regulated GMP environment.

Key Responsibilities

• Lead and execute Computer System Validation (CSV) activities for automation upgrade projects involving HMI and PLC systems.
• Support 2–3 site-based automation upgrades, including system lifecycle documentation (URS, FRS, IQ/OQ/PQ, RTM).
• Ensure all validation activities comply with GxP, FDA, EMA, and 21 CFR Part 11 requirements.
• Collaborate closely with Automation, Engineering, Quality, and IT stakeholders to support successful project delivery.
• Participate in and support validation activities during the summer shutdown period (no planned leave during this time).
• Provide on-site support at the Cork facility in line with the hybrid working model.

Required Qualifications & Experience

• 5–10 years of CSV experience within the pharmaceutical or life sciences industry.
• Proven hands-on experience validating automation systems, including Siemens PLCs and HMIs.
• Strong knowledge of GMP-regulated manufacturing environments.
• Experience supporting automation upgrades and remediation projects.
• Solid understanding of CSV lifecycle methodologies and regulatory expectations.
• Ability to work independently and manage multiple workstreams.

Additional Requirements

• Immediate availability or short notice preferred.
• Willingness to work on-site in Cork 3 days per week.
• Availability to support critical activities during the summer shutdown period.
• Prior experience working on site-wide automation upgrades in pharmaceutical manufacturing.
• Familiarity with data integrity requirements and risk-based validation approaches.