Catalyx is seeking an Automation Project Lead to join our team and support an established group based on a customer site in Cork.
This is an initial 6 month project with the possibility of extension.
Who We Are: Catalyx specialises in the science of operational processes.
With a footprint across North America and Europe, the company automates and supports R&D, production, packaging, and delivery processes across highly regulated industries.
Formed in 2022 through the merger of CXV Global (Crest Solutions, Xyntek, and Vista Link) and Panacea Technologies, Catalyx brings over three decades of experience delivering compliant, scalable automation solutions for life sciences clients.
The Role: The position sits at the intersection of automation, computerised system validation, and regulated operations, and would suit someone with experience working on complex automated equipment and software-driven systems within pharmaceutical or biotech manufacturing environments, including packaging or serialisation-type systems.
The successful candidate will take ownership of project delivery, lead qualification and validation activities, and coordinate across site teams, global stakeholders, and external vendors.
Responsibilities: Lead the setup and delivery of automation projects from concept through to implementation.
Manage equipment qualification and computerised system validation activities in Gx P environments.
Assess and challenge automation and software solutions to ensure regulatory compliance, data integrity, and operational robustness.
Plan, execute, and manage change controls associated with new or modified automated systems.
Act as the technical point of contact for automation implementation and system integration activities.
Collaborate with site and global teams to align on automation standards, approaches, and best practices.
Coordinate with vendors and system suppliers on system specifications, configuration, testing, and handover.
Develop and maintain project documentation including user requirements, validation protocols, and traceability.
Support troubleshooting, deviation investigations, and continuous improvement initiatives related to automated systems.
Ensure all activities comply with Gx P, data integrity, and applicable regulatory requirements.
Requirements: Experience in automation, CSV, IT, engineering, or technical project roles within Gx P-regulated environments.
Demonstrated experience with equipment qualification and computerised system validation.
Strong understanding of data integrity principles and regulated system compliance.
Experience delivering or supporting automation projects involving complex equipment and integrated systems.
Comfortable managing change controls and engaging with vendors, integrators, and internal stakeholders.
Strong communication, documentation, and organisational skills.
Detail-oriented, self-motivated, and capable of working independently.
Able to operate effectively in fast-paced, regulated, and cross-functional environments.
Requirements: Background in automation, engineering, CSV, IT, or technical project roles within Gx P-regulated pharmaceutical or biotech environments.
Hands-on experience supporting or leading equipment qualification and computerised system validation activities.
Experience working with complex automated equipment and software-driven systems, such as those found in packaging, serialisation, manufacturing, or laboratory environments.
Solid understanding of data integrity principles and regulatory expectations for automated systems.
Experience managing or supporting change control activities for new or modified systems.
Ability to interface effectively with vendors, system integrators, and internal site stakeholders.
Strong documentation skills, with experience producing and reviewing regulated project and validation documentation.
Proven ability to work independently and take ownership of technical deliverables.
Comfortable operating in fast-paced, cross-functional, and highly regulated environments.
Strong communication and organisational skills, with the ability to explain technical topics to non-technical stakeholders.
Why Join Catalyx? At Catalyx, our people are our greatest asset.
We offer a comprehensive Total Rewards package alongside strong professional development and growth opportunities.
Our teams work on technically challenging, high-impact projects in collaborative and inclusive environments.
Catalyx is an Equal Opportunity Employer.
We are committed to building a diverse and inclusive workplace where all individuals are valued, respected, and supported.
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