Principal QC IT System Analyst, LIMS and Empower

The Principal QC IT System Analyst is is a senior professional who works independently with minimal guidance, acts as a resource for colleagues, and may lead small-to-medium projects or processes. The role ensures reliable, secure, and compliant operation of QC informatics applications (primarily LabWare LIMS and Waters Empower) and related integrations across the lifecycle. This role partners with QC, QA/CSV, Validation, Global IT, Cybersecurity, Manufacturing, and vendors to plan and execute changes, maintain validated state (GxP/CSV), and drive continuous improvement that enhances QC throughput, data integrity (ALCOA ), and inspection readiness. The incumbent solves complex problems by taking a new perspective on existing solutions and uses judgment based on the analysis of multiple sources of information in alignment with FUJIFILM Biotechnologies Global standards and procedures.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.

Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki.

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

• Service Delivery and Tier-2/3 Support: Delivers timely, expert support for LIMS/Empower and related QC applications; monitors SLAs, trends incidents/problems, and implements corrective and preventive actions to sustain operations.
• System Reliability, Availability, and Security: Administers user/role management, configurations, patching, backups, archiving, license management, and integrations; partners with Cybersecurity/Global IT to address vulnerabilities and risks.
• ITSM/ITIL Execution and Process Improvement: Executes and refines incident, problem, change, configuration, and release processes; authors/updates SOPs and work instructions to improve efficiency, stability, and compliance.
• GxP Compliance, CSV, and Documentation: Authors/reviews/approves risk assessments, validation plans/protocols/reports, and IT QMS documentation; maintains validated state per cGMP, 21 CFR Part 11, EU Annex 11, Annex 15, GAMP 5.
• Project and Enhancement Delivery: Plans and leads small-to-medium upgrades, enhancements, and integrations; manages scope, schedule, budget, and quality; applies risk-based validation and robust change control.
• Vendor and Service Provider Management: Serves as primary site liaison with LabWare and Waters; negotiates priorities and deliverables, drives root-cause resolution, and ensures contracted value and compliance outcomes.
• Work Direction and Mentoring: Provides day-to-day guidance and work direction to up to 3 analysts/administrators; mentors colleagues, coordinates workload, and contributes input to performance discussions per FUJIFILM Biotechnologies Global expectations.
• Continuous Improvement and Standardization: Simplifies and standardizes procedures, dashboards, and metrics; champions data lifecycle controls and data integrity; identifies automation opportunities across workflows.
• Metrics, Reporting, and Inspection Readiness: Defines and reports KPIs (e.g., uptime, incident backlog, change success rate, validation cycle times); prepares audit/inspection evidence and provides authoritative system responses.
• Stakeholder Engagement and Communication: Communicates plans, risks, cutover strategies, and impacts to QC leadership and cross-functional partners; aligns release schedules to minimize disruption.
  
  

Minimum Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering, or related field required.
• Advanced degree (MS/MEng) preferred.
• An equivalent combination of education and relevant experience may be considered per FUJIFILM Biotechnologies Global guidelines.
  
  

Preferred Qualifications

• 12 years of progressive IT experience, including 5 years supporting GxP-regulated systems in pharmaceutical/biologics environments.
• 3 years hands-on administration with LabWare LIMS and 3 years with Waters Empower (e.g., configuration, upgrades/patching, user/role administration, integrations, license management).
• 3 years leading small-to-medium projects or workstreams with scope/schedule/budget accountability, applying risk-based CSV and change control.
• Demonstrated audit/inspection support experience and strong familiarity with ITIL/ITSM processes.
  
  

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to 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 (fdbglobaltalent@fujifilm.com).