LIMS Implementation Coordinator (Contract)

Position Summary

We are seeking a LIMS Implementation Coordinator to support the implementation of Caliber LIMS in a GxP environment. This role works under the guidance of a senior LIMS implementation lead and coordinates activities across laboratories, IT, QA, and vendor stakeholders. The position blends project coordination, documentation, and hands-on implementation support.

Essential Duties & Responsibilities

• Cook up day-to-day Caliber LIMS implementation activities across lab, IT, QA, and external vendor teams
• Support configuration and hands-on build activities under the direction of the senior implementation lead
• Author and maintain implementation documentation (URS inputs, configuration specifications, test scripts, training materials)
• Plan and support User Acceptance Testing (UAT) - scheduling, script execution support, and defect tracking
• Support data migration activities from legacy systems into Caliber LIMS
• Contribute to validation deliverables aligned with 21 CFR Part 11, GxP, and EMA requirements
• Communicate progress, risks, and issues to the Director of IT and project stakeholders

Position Requirements and Qualifications

• Bachelor's degree in Life Sciences, Engineering, IT, or a lab-based role in life sciences with 3+ years of relevant experience; OR Master's degree with 1–2 years of relevant experience
• Prior exposure to LIMS implementation, configuration, or support in a regulated environment
• Working understanding of 21 CFR Part 11 and GxP principles
• Strong documentation and coordination skills; ability to manage multiple workstreams under deadlines
• Able to work onsite in Chicago, IL

Experience

• Direct experience with Caliber LIMS
• Candidates with comparable LIMS platform experience (LabWare, LabVantage, STARLIMS, Sample Manager) considered a priority
• Familiarity with GAMP 5 principles
• Experience supporting UAT and test execution in a validated environment
• Prior experience in pharmaceutical, biotech, or diagnostics lab settings

Specialized Knowledge and Skills

• Familiarity with GAMP 5 principles and risk-based validation
• Exposure to Caliber LIMS
• Exposure to SAP (QM, MM, PP) in a GxP context
• Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams

Work Environment & Physical Demands

• This is an on-site position at our Chicago, IL location
• Must be able to work extended hours or weekend hours, as may be required

Noise

• No extraordinary noise levels

Standing/Lifting

• Very unlikely, but can be able to lift at least 20 lbs.

Visual

• No extraordinary requirements

Stress

• High-paced demanding environment to meet ambitious project goals

Travel

• Moderate domestic travel may be required