QC LIMS Developer

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Paid time off

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a QC LIMS Developer to design, configure, validate, and support LIMS for QC labs, ensuring GMP compliance and on-time release of products.

You will build digital workflows, integrate instruments, and generate dashboards while aligning with QA, validation, IT, and manufacturing teams in a fast-paced, regulated environment.

Qualifications

• Bachelor’s degree in a relevant field; GMP/regulated environment preferred.
• 3–7 years configuring and supporting LIMS in GMP settings.
• Hands-on with LIMS platforms (LabWare, LabVantage, etc.) and CSV familiarity.
• Understanding QC workflows and regulatory requirements.

Responsibilities

• Translate QC requirements into LIMS workflows (login, testing, results, CoA).
• Configure master data: tests, specs, limits, instruments, users, security.
• Build dashboards/reports (KPIs, turnaround time, EM trends).
• Integrate instruments/systems (CDS, ELN, ERP).
• Support validation, change control, and audits; ensure data integrity.

Skills

Analytical skills

Problem solving

Stakeholder mgmt

Documentation

Requirements gathering

Education

Bachelor's in CS/IS or related

Master's degree a plus

Tools

LabWare LIMS

LabVantage

SampleManager

Nautilus

STARLIMS

SQL

Oracle

SQL Server

Power BI

Crystal Reports

JasperReports

Job description

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.

Company Overview

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do:

• 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.

Qualifications

• 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., LabWare, LabVantage, SampleManager, 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).

Knowledge & Capabilities:

• Scripting/config: SQL; LabWare LIMS Basic or LabVantage Java/Groovy; .NET/Java/Python for integrations; XML/JSON.
• Databases: Oracle and/or SQL Server
• Interfaces: file-based integrations; experience with CDS (Empower/Chromeleon), ELN/LES, and label systems.
• Reporting: Crystal Reports, Jasper, Power BI/Tableau; LIMS native query/report tools.

• Strong requirements gathering, documentation, and communication.

• Analytical problem solving; ability to translate lab needs into scalable, compliant solutions.

• Stakeholder management and training aptitude; comfortable in fast-paced, regulated settings.

• Strong analytical and problem‑solving skills.

Preferred Qualifications

• Knowledge of LabWare LIMS version 8 table relationships.

• Experience with Crystal reports.

• Excellent verbal and written communication skills.

Physical Requirements:

• Will work in environment which may necessitate respiratory protection
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time (240 minutes)
• Ability to sit for prolonged periods of time (240 minutes)
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers
• Ability to conduct work that includes moving objects up to 33lbs
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
• Will work in warm/cold environments (0-100F range)

Benefits

Our programs are designed to focus on maintainingand enhancing all pillars of health with arobust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading401(k) savings plan, insurance coverage, employee assistanceprograms and various wellness incentives. We support life-work balance withpaid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).