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.
Skills Required
- Bachelor's degree in Life Sciences, Engineering, IT, or lab-based role with 3+ years relevant experience; OR Master's degree with 1-2 years relevant experience
- Prior exposure to LIMS implementation, configuration, or support in a regulated environment
- Understanding of 21 CFR Part 11 and GxP principles
- Strong documentation and coordination skills; ability to manage multiple workstreams under deadlines
- Direct experience with Caliber LIMS or comparable platforms
- Familiarity with GAMP 5 principles
- Experience supporting UAT and test execution in a validated environment
What We Do
Kashiv BioSciences is a fully-integrated biopharmaceutical company with global R&D, clinical, manufacturing, regulatory, and IP capabilities, focusing on developing and manufacturing biosimilars and complex peptide medicines to improve access to important therapies.
