LIMS Implementation Coordinator (Contract)

LIMS Implementation Coordinator (Contract) Kashiv BioSciences, LLC•2.4 Chicago, IL Job Details Contract $65•$75 an hour 3 hours ago Qualifications Project team coordination GAMP Pharmaceutical regulatory compliance SAP Materials Management Laboratory information management systems

FDA 21 CFR

Part 11 SAP Quality Management (QM) Collaboration with manufacturing teams

Full Job Description Description:

Position Type:

Contractor / Consultant•FTC (6-9 Months with possible extension)

Location:

Chicago, IL (onsite•physical presence required)

Reports To:

Sr.

Director of IT Rate:

$65•75/hour, not overtime eligible

Work Authorization:

Must be authorized to work in the U.S. without sponsorship, now or in the future Job Description 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 Coordinate 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

Requirements:

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 Ability 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.