QC LIMS Developer: GMP-Driven Lab Automation Expert

FUJIFILM Biotechnologies

Milwaukee (WI)

On-site

USD 90,000 - 130,000

Full time

6 days ago
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Benefits offered by this job

Medical, dental, vision coverage
401(k) savings plan
Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies seeks an LIMS Developer to design, configure, validate, and support QC LIMS workflows for sample lifecycle management and compliant reporting. You will build dashboards, integrate instruments and systems, and ensure data integrity and on-time product release in a GMP environment.

You will also author CSV documents (URS/FRS/HDS) and lead validation efforts while collaborating with QC, QA, IT, and Manufacturing to align solutions with right-first-time goals.

Qualifications

  • Bachelor’s in CS/IS or related field; pharma/biotech GMP experience preferred.
  • 3–7 years configuring and supporting LIMS in GMP environments.
  • Hands-on with LabWare, LabVantage, SampleManager, Nautilus or STARLIMS.

Responsibilities

  • Translate QC requirements into LIMS workflows (login, testing, results, CoA).
  • Configure master data: tests, specs, units, instruments, users, security.
  • Build dashboards and reports using LIMS tools and BI platforms.
  • Integrate instruments and systems (CDS, ELN, ERP).
  • Lead validation activities (IQ/OQ/PQ) and maintain 21 CFR Part 11 compliance.

Skills

LIMS configuration
SQL
LabWare LIMS
LabVantage
SampleManager
STARLIMS
Informatics integrations
GxP/compliance
Validation (IQ/OQ/PQ)

Education

Bachelor's degree in CS/IS/related
Chemistry/Biochemistry background
Master's degree (plus)

Tools

Crystal Reports
JasperReports
Power BI/Tableau
XML/JSON interfaces
ERP integrations (SAP/Oracle)

Job description

FUJIFILM Biotechnologies seeks an LIMS Developer to design, configure, validate, and support QC LIMS workflows for sample lifecycle management and compliant reporting. You will build dashboards, integrate instruments and systems, and ensure data integrity and on-time product release in a GMP environment.

You will also author CSV documents (URS/FRS/HDS) and lead validation efforts while collaborating with QC, QA, IT, and Manufacturing to align solutions with right-first-time goals.

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