Principal QC IT System Analyst, LIMS and Empower

Fujifilm•Research Triangle Park, NC

About The Position

The Principal QC IT System Analyst 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.

Requirements

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

Nice To Haves

Advanced degree (MS/MEng) preferred.

Responsibilities

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.
Administers user/role management, configurations, patching, backups, archiving, license management, and integrations; partners with Cybersecurity/Global IT to address vulnerabilities and risks.
Executes and refines incident, problem, change, configuration, and release processes; authors/updates SOPs and work instructions to improve efficiency, stability, and compliance.
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.
Plans and leads small-to-medium upgrades, enhancements, and integrations; manages scope, schedule, budget, and quality; applies risk-based validation and robust change control.
Serves as primary site liaison with LabWare and Waters; negotiates priorities and deliverables, drives root-cause resolution, and ensures contracted value and compliance outcomes.
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.
Simplifies and standardizes procedures, dashboards, and metrics; champions data lifecycle controls and data integrity; identifies automation opportunities across workflows.
Defines and reports KPIs (e.g., uptime, incident backlog, change success rate, validation cycle times); prepares audit/inspection evidence and provides authoritative system responses.
Communicates plans, risks, cutover strategies, and impacts to QC leadership and cross-functional partners; aligns release schedules to minimize disruption.