Job Summary

At Kedrion Biopharma, every step of our manufacturing process contributes to therapies that improve and save lives for people with rare and serious conditions. As a LIMS Administrator Specialist, you’ll be part of the team responsible for the configuration, maintenance, optimization and operational support of the LIMS system, ensuring full compliance with quality regulations and maximum efficiency of QC and QA laboratory processes. The role involves strong collaboration with both laboratory teams and corporate functions, for the validation of new functionalities, and the management of new flows and master data.

What you'll do

• Management and updating of master data (parameters, test methods, product specifications, sampling plans).
• Implementing new features and system updates in collaboration with vendors, IT, and corporate functions.
• Coordination with corporate functions for the validation of new functionalities, the management of new flows and the governance of master data.
• Management of interfaces between LIMS and other business systems (e.g. SAP).
• Support end users for the resolution of technical and operational problems.
• Development and updating of SOPs, user manuals and system documentation.
• Provision of specific training for laboratory and QA/QC personnel on the use of LIMS.
• Ensure system compliance with GMP, GxP and corporate data integrity policies.
• Participation in internal and external audits, providing evidence and required documentation.
• Management of system validation processes (URS, OQ, PQ).
• Analysis and continuous improvement of laboratory workflows through the automation and digitization of processes.
• Collaboration with lab managers and corporate functions to implement new features and optimize QC and QA activities.
• Support QC Laboratories functions as needed.
• May perform other duties as assigned.
• Specific training plan to be provided.

Qualifications and need-to-know

• Bachelor’s Degree in scientific disciplines (Chemistry, Biology, Biotechnology or similar) or computer science.
• Skills in data integrity and cybersecurity applied to laboratory systems.
• At least 1 years’ experience in the management of LIMS systems in the pharmaceutical or biotechnology field.
• Effective communication with internal teams, corporate functions and suppliers, even in complex or international contexts.
• Teamwork and collaboration, both at local and corporate level.
• Ability to actively listen to users and stakeholders.
• Priority management and organization.
• Flexibility and adaptability to process changes and new technologies.
• Orientation towards continuous improvement.
• Cross-functional leadership to drive cross-functional activities.
• Conflict management and mediation between different needs.
• Knowledge of QC and QA GMP flows, including the ability to map, optimize, and digitize processes according to current regulations.
• Knowledge of GMP/GxP regulations and QC/QA laboratory processes.
• Ability to configure, validate, and maintain LIMS systems (preferably LabWare or equivalent).
• Excellent skills in problem solving, project management and working in multidisciplinary teams.
• Good knowledge of the English language
• Occasional travel (up to 10%) is required, including overnight stays and international trips. This includes visits to Kedrion locations, regional meetings, and official company functions.