LIMS Project Analyst

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LIMS Project Analyst

Our client, a Biotech manufacturing based in South Dublin, is looking for a LIMS Project Analyst.

Reporting to the Head of Quality Systems, The LIMS Project Analyst is tasked with ensuring the efficient implementation of LIMS Labware V8, in line with industry best practices to fulfil company’s local expectations. This includes proactively developing, implementing, LIMS Master data to support manufacture, testing, and product release processes.

Responsibilities

• Configuration or modification of LIMS setups, encompassing microbiology or QC Analytical methods, product specifications, schedulers, standards & reagents, COA’s, Label and printer setup, and associated LIMS Master Data.
• Generation and verification of LIMS Master Data as necessary.
• Conducting of informal and formal verification testing of the configured LIMS solution in collaboration with Computer Systems Validation (CSV) project resources.
• Generation of Test Scripts/Test Protocols for formal LIMS test execution as required.
• Supporting end users in terms of training materials and execution, troubleshooting during hyper-care stages, and escalating issues to IT or LIMS Administrators.
• Contribution to the development of LIMS Configuration/Design Specifications and Design Note documentation.
• Analysing user requirements and LIMS design alongside with business users and associated team members.
• Configuration of interfaces between LIMS and Analytical Equipment or associated software, and interfaces to SAP where required.
• Hosting facilitated review workshops with users to walk them through the configured LIMS, making updates prior to design completion and testing.
• Collaborating with various stakeholders, including business/QA/QC/Manufacturing, Project Manager, Labware technical SMEs, and in-house LIMS Administrators.
• Coordinating identified elements of the LIMS project stream, including task management, stakeholder follow-ups, supplier follow-ups, and issue escalation.
• Undertaking other LIMS-related tasks assigned by the Project Lead/Project Manager.

Requirements

• Bachelor’s degree in a life sciences, IT or a related scientific discipline.
• A minimum of 1 years’ LIMs administration / Master Data Building.
• In-depth understanding of quality systems and cGMP’s.
• Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas. Specific experience in cell therapy is an advantage.

Desirable skills
• Previous experience in Master Data Building and / or maintenance of LIMS data.
• Excellent communication and interpersonal skills.
• Strong sense of ownership and accountability for results.
• Demonstrating a confident, pragmatic, collaborative, and positive/proactive approach with strong communication skills