LIMS Implementation Coordinator (Contract)
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Kashiv Biosciences LLC
Chicago, IL, US
Summary
Coordinate the implementation of Caliber LIMS across laboratory, IT, and QA teams while managing documentation and configuration activities. Support User Acceptance Testing, data migration, and validation deliverables to ensure compliance with GxP and 21 CFR Part 11.
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.
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
Founded
2011
Company size
201-500 employees
Industry
Pharmaceutical Manufacturing
Org type
Privately Held
Headquarters
Bridgewater, New Jersey
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
Founded
2011
Company size
201-500 employees
Industry
Pharmaceutical Manufacturing
Org type
Privately Held
Headquarters
Bridgewater, New Jersey