QC LIMS Developer - GMP Data Automation & Validation

FUJIFILM Electronic Materials (Europe) N.V.; North Carolina; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid vacation

Job summary

FUJIFILM Biotechnologies is seeking a QC LIMS Developer to design, configure, validate, and support LIMS capabilities for Quality Control laboratories in North Carolina. You will build compliant workflows for sample login, testing, results, CoA generation, and reporting while ensuring data integrity and GMP compliance.

The role involves integrations with CDS/ELN/ERP systems, validation activities, and ongoing operations support.

Qualifications

• Bachelor’s in CS/IS or related field; Master’s a plus.
• 3–7 years configuring and supporting LIMS in GMP environments (pharma/biotech/medical device).
• Hands-on with LabWare, LabVantage, SampleManager, Nautilus, STARLIMS; CSV experience and regulatory familiarity.

Responsibilities

• Design and configure LIMS workflows to support QC sample lifecycle and reporting.
• Integrate instruments and systems (CDS, ELN, ERP) and automate calculations.
• Ensure 21 CFR Part 11 / EU Annex 11 compliance and conduct validation activities.
• Provide application support, manage environments/releases, and train end users.
• Identify digital improvements to reduce cycle time and errors.

Skills

LIMS configuration

GxP compliance

SQL scripting

Data integrity

Stakeholder management

Education

Bachelor's in Computer Science/Information Systems

Master's degree (aPlus)

Tools

LabWare LIMS

LabVantage

SampleManager

Nautilus

STARLIMS

Job description

FUJIFILM Biotechnologies is seeking a QC LIMS Developer to design, configure, validate, and support LIMS capabilities for Quality Control laboratories in North Carolina. You will build compliant workflows for sample login, testing, results, CoA generation, and reporting while ensuring data integrity and GMP compliance.

The role involves integrations with CDS/ELN/ERP systems, validation activities, and ongoing operations support.