LIMS Site Implementation Lead

Summary:
A biopharmaceutical company in Waterford requires a LIMS Site Implementation Lead to support the implementation of a new site-wide LIMS. The successful candidate will be responsible for coordinating configuration, stakeholder engagement, and phased deployment to support quality control, laboratory operations, and data integrity across the site.

Responsibilities:

• Conduct gap analysis and pre-scoping workshops to identify system configuration requirements.
• Support the deployment of a core Laboratory Information Management System (LIMS) model at site level.
• Enable and manage LIMS functionalities including: QC instrument management, QC reagent management, QC sample management, raw material management, finished product management and stability testing management.
• Activate and coordinate interfaces with partner or enterprise systems (for example ERP platforms).
• Ensure capability for laboratory instrument connectivity and data integration is established and maintained.
• Performing diagnostic & analysis of current performance.
• Delivering relevant business case for implementation.
• Simplifying business process with SME before deploying the Digital solution.
• Implementing E2E the selected Smart Factory solutions through defined gates with team coordination, budget and planning management.
• Managing change management and communication plan.
• Setting the site Community of Practices and proposing improvement features to Global Product owners, then transitioning to Business System Owner.
• Performance diagnostic on the relevant scope.
• Site road map execution for the related solution.
• Global Site Digital road map.
• Global Site performance plan.
• Value realization of the Digital solution.

Qualifications & Experience:

•  Bachelor’s degree (or higher) in Life Sciences, Chemistry, Biochemistry, Engineering, or a related scientific or technical discipline.
• Minimum 8+ years of relevant experience within a pharmaceutical or biopharmaceutical manufacturing environment.
• Strong QC laboratory background, with hands-on experience in laboratory processes, testing workflows, documentation practices, and compliance within GMP-regulated environments.
• Proven experience working with and/or implementing Laboratory Information Management Systems (LIMS), including configuration, user support, and system integration with laboratory instruments or enterprise systems.
• Demonstrated project management experience, coordinating cross-functional teams, timelines, and deliverables in complex site or digital transformation projects.
• Solid understanding of GMP, data integrity, and regulatory requirements impacting laboratory and manufacturing operations.
• Excellent communication, stakeholder engagement, and organisational skills, with the ability to work effectively across technical, quality, and operational teams.
• SMS certified would be desired.
• Good understanding of data management and IA digital products.