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.