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Sanofi's contingent workforce program, FLEXT Direct, is seeking a LabWare LIMS Administrator for a 7-month contract with possibility of extension.
Position Overview
The Lab Information Management System (LIMS) Business Administrator is essential to Quality Operations at the Swiftwater site, supporting the maintenance and improvement of the LIMS system.
Maintenance support will include:
Supporting Business and IS LIMS Administrators in report design and build
Updating master data for new and existing products
Updating master data for new and existing analyses
Maintaining system documentation
Providing ad hoc support to other departments
This position is expected to provide leadership in support of system evolution, continuous improvement initiatives, and laboratory informatics needs.
The role will also support the creation of new master data for Raw Materials within the ONE LIMS Global System, including translation of data from existing electronic systems for use in mass upload tools and configuration activities.
Position Responsibilities
Ensure site on-time implementation of OneLIMS Raw Materials activities through support of master data requirements definition, functional design, master data configuration, data migration, site system validation, SOP revisions, and development of end-user training
Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability, and R&D operations
Support Business and Global IS LIMS Administrators in the creation, validation, and maintenance of reports, calculations, and queries
Provide first-level diagnostic support for incidents and assist business users, IS LIMS Administrators, and Support Center teams with timely resolution of technical issues
Support master data management processes including updating specifications, analyses, approvals, and verification processes
Manage Global System updates and changes, including new modules and workflow changes
Configure and maintain instrument interfaces to laboratory equipment
Support the definition, approval, and validation of new business requirements
Ensure LIMS compliance with all relevant regulatory standards
Support the creation and updating of training materials as system changes occur
Technical Competencies & Soft Skills
Working knowledge of aseptic processes, biology, chemistry, or life sciences environments
Strong understanding of cGMPs and regulatory requirements
Strong analytical, problem-solving, and balanced decision-making skills
Excellent communication and collaboration skills
Ability to lead and participate effectively within cross-functional teams
Basic Requirements
3+ years of experience using and administering LabWare LIMS, including LIMS Basic
Strong working knowledge of laboratory processes and cGMPs within a pharmaceutical environment
Experience with system testing, validation, and master data management
Familiarity with 21 CFR Part 11 data integrity best practices within pharmaceutical environments
Excellent written and verbal communication skills
Experience working within laboratory environments
Preferred Qualifications
Experience with laboratory systems such as Empower, Crystal Reports, NuGenesis, LabX, SAP, or related laboratory instrument control/acquisition systems
Experience with SQL and database structures
Strong project management skills
Experience migrating master data from LabWare V6 to LabWare V8
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