QC LIMS Developer

About the role

At FUJIFILM Biotechnologies, 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.

Responsibilities

• 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.

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 (0-100°F range).

Benefits

• Medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions.
• Industry-leading 401(k) savings plan with company contributions.
• Employee assistance programs and various wellness incentives.
• Paid vacation time, sick time, and company holidays.