LIMS Specialist

Category: Pharmaceutical

The Laboratory Information Systems (LIMS) Specialist is responsible for supporting site business in static data management.

This position is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures and global data standards.

Working remotely this role will support LIMS for the Dublin based Bio pharmaceutical company, initially an 11 month contract with a view to extension. Please apply today for more details.

Role:

Act as point-of-contact for LIMS supporting site-based customers including laboratories, IPT areas, and regulatory inspection requests.
• Processes change controls for the LIMS system following applicable procedures.
• Serve as Labware LIMS expert to support/train business users that include performing dynamic data corrections, data extraction/reporting, and lead or support LIMS related investigations.
• Collaborates with the site business to clearly define business needs into LIMS requirements.
• Perform site LIMS impact assessment including impact to other functional areas/systems and anticipate risks.
• Work and collaborate with a distributed team including those from the site Laboratories and IPT areas,
• Prioritizes changes by the target due date, builds trust with customers by ensuring on time implementation of changes and drives results by overcoming obstacles.
• Ability to execute LIMS build per requirements and global data standards.
• Responsible for driving and maintaining static data standardization and process harmonization across the GLIMS network.
• Experience with Acceptance Testing procedures, coordinates and supports business requestor /change owner in confirmation of requirements, design, and build. perform technical review of test protocols – pre and post execution.
• Perform technical review and approval of change documents to ensure accuracy, compliance, integrity, completeness, and coordinate site pre-approvals.
• Support the business in the creation and updating of training materials as changes to system occur.
• Complete technical assignments independently once specific objectives have been defined.
• Act as first line of support to troubleshoot incidents reported at site,

Education and Essential requirements

• Bachelor’s Degree or higher in Chemistry, Biological or Computer Science
• A minimum of 4 years of LIMS hands-on experience in a pharmaceutical environment with LabWare LIMS v6 (or higher) static data configuration including developing analyses, product specifications, and calculations.
• In depth knowledge and experience on the Labware LIMS modules, primarily Stability, Lot Management, Standards and Reagents, Environment Monitoring, Project Manager, Storage Location manager, and use of Querying tools.
• Familiarity and/or experience with Labware LIMS Basic to build/update calculations.
• Candidate must have knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
• Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
• Possesses the ability to translate Standards (Data/Process) and “Digital transformation” vision into execution projects
• Exhibit ability to learn new features and functions in LIMS and related systems and can increasingly handle more complex issues and requests
• Ability to build and run SQL queries for Ad hoc reporting/querying