LIMS Project Analyst

• Configuration or modification of LIMS setups, including microbiology or QC analytical methods, product specifications, schedulers, standards & reagents, COAs, label and printer setup, and related LIMS Master Data.
• Generation and review of LIMS Master Data as required.
• Execution of informal and formal verification testing of the configured LIMS solution in collaboration with Computer Systems Validation (CSV) project resources.
• Development of Test Scripts and Test Protocols to support formal LIMS test execution, where required.
• Supporting end users through preparation and delivery of training materials, troubleshooting during hyper-care phases, and escalation of issues to IT or LIMS Administrators as appropriate.
• Contributing to the development of LIMS Configuration/Design Specifications and Design Note documentation.
• Analysing user requirements and LIMS design in collaboration with business users and relevant team members.
• Configuration of interfaces between LIMS and analytical equipment, associated software, and SAP where required.
• Facilitating review workshops with users to walk through configured LIMS solutions and implement updates prior to design finalisation and testing.
• Collaborating with key stakeholders, including Business, QA, QC, Manufacturing, the Project Manager, LabWare technical SMEs, and in-house LIMS Administrators.
• Coordinating identified elements of the LIMS project stream, including task tracking, stakeholder and supplier follow-ups, and issue escalation.
• Performing other LIMS-related activities as assigned by the Project Lead/Project Manager.
• 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.

• 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.

• 1+ year of LIMS administration and/or Master Data building experience.
• Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing.
• Thorough understanding of quality systems and cGMPs.

• Experience in Master Data building and/or maintenance of LIMS data.
• Excellent communication and interpersonal skills, with a proven ability to influence and collaborate effectively with cross-functional teams and external stakeholders.
• Demonstrates a confident, pragmatic, collaborative, and proactive approach, with strong communication skills.
• Ability to work independently and as part of a team, with a strong sense of ownership and accountability for results.

Asset Recruitment