QC LIMS Developer

Position Overview

The QC LIMS Developer designs, configures, validates, and supports Laboratory Information Management System (LIMS) capabilities for Quality Control laboratories. This role builds compliant digital workflows for sample lifecycle, stability, specifications, CoAs, instrument/data integrations, and reporting, ensuring data integrity, GMP compliance, and on-time product/material release.

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

• Solution design and configuration

  • Translate QC business requirements into LIMS workflows (sample login, testing, results entry/review/approval, CoA generation, stability, EM, utilities, raw materials, in-process/finished product).

  • Configure master data: tests, methods, specifications, limits, calculations, units, instruments, users/roles, security, audit trails, electronic signatures.

  • Build dashboards, queries, and reports (KPIs, turnaround time, RFT metrics, EM trending, stability pulls) using native LIMS tools and reporting platforms.

• Integrations and automation

  • Integrate instruments and systems (CDS such as Empower; ELN; ERP like SAP/Oracle)

  • Implement results parsing and automated calculations; manage instrument metadata and result mapping.

• Compliance and validation (GxP)

  • Author and execute CSV deliverables: URS, FRS, HDS, configuration specs, risk assessments, test scripts (IQ/OQ/PQ), validation summary reports.

  • Ensure 21 CFR Part 11 / EU Annex 11 adherence, ALCOA+ data integrity, and Good Documentation Practices; maintain change control and periodic review.

  • Support audits/inspections; maintain audit-readiness for LIMS and connected systems.

• Operations and support

  • Provide application support, incident/problem management, and root-cause analysis; monitor job/integration health and performance.

  • Manage environments and releases (dev/test/qual/prod), versioning, and migrations; follow SDLC and Agile/Scrum practices.

  • Lead data migration/cleanup projects; build scripts for bulk loads and master data maintenance.

  • Create user guides/SOPs/WIs; train end users (multiple departments).

• Continuous improvement

  • Identify digital opportunities to reduce cycle time and errors; implement templates, macros, and standardized builds across sites/products.

  • Partner with QC, QA, Validation/CSV, IT Security, and Manufacturing to align solutions with contamination control strategy and right-first-time goals.

• Bachelor’s in Computer Science/Information Systems, Chemistry, Biochemistry, or related field;
  Master’s a plus.

• 3–7 years configuring and supporting LIMS in GMP environments (pharma/biotech/med device).

  • Hands‑on with one or more platforms (e.g., Lab Ware, Lab Vantage, Sample Manager, Nautilus, STARLIMS).

  • Proven CSV experience and familiarity with FDA 21 CFR 210/211/11, EU Annex 11, GAMP 5, ICH Q9/Q10.

  • Understanding of QC lab processes (raw materials, compendial testing, stability, EM/utilities, microbiology, chromatography workflows).

• Scripting/config: SQL;
  Lab Ware LIMS Basic or Lab Vantage Java/Groovy; .NET/Java/Python for integrations; XML/JSON.
• Databases:
  Oracle and/or SQL Server
• Interfaces:…