LIMS Implementation & Integration Manager

Job Title: LIMS Implementation & Integration Manager

Job Responsibilities:

• Own end-to-end delivery of LIMS (CaliberLIMS Preferred) implementation programs, ensuring alignment with laboratory operations, business goals, and regulatory requirements.
• Lead requirement gathering, solution design, and system configuration including workflows, and user roles/permissions.
• Manage project planning, timelines, risks, & resource allocation to ensure successful and timely delivery.
• Drive integration of LIMS with Lab Instrument including Port based, File based and CDS (Empower) and enterprise systems (such as SAP and TrackWise) ensuring data integrity and system performance.
• Ensure compliance with GxP standards (GMP, GLP, FDA, 21 CFR Part 11) and lead Computer System Validation (CSV) activities.
• Act as the primary liaison between business stakeholders, IT teams, QA, and external vendors, ensuring clear communication and alignment.
• Lead user enablement including training strategy, SOP development, documentation, and change management for successful adoption.
• Establish post-go-live support, continuous improvement initiatives, and system enhancements to optimize performance and user experience.