Senior QC IT System Analyst - LIMS or Empower

Fujifilm • Morrisville, NC

7d

About The Position

As a Senior QC IT System Analyst, you will own day-to-day operations, reliability, and continuous improvement of QC IT applications—particularly LabWare LIMS and Waters Empower. You’ll serve as the primary site contact for vendors, lead upgrades and releases, ensure systems remain in a validated state, and provide expert second-level support. You will guide up to three team members, collaborate across Quality, IT, and Manufacturing, and play a key role in audit/inspection readiness and GxP compliance. This is a hands-on, high-visibility role for a systems leader who thrives at the intersection of technology, quality, and operations.

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.”

Make an impact where quality meets technology. Join a high-performing team that keeps critical QC laboratory systems running flawlessly, drives continuous improvement, and upholds data integrity and compliance standards across a global biologics/pharmaceutical environment.

Requirements

• Bachelor’s degree in a related discipline (IT or Computer Science) is required OR a Master’s degree with 2+ years of related experience.
• 5+ years of experience in the IT field and/or pharmaceutical industry.
• 5+ years of relevant experience demonstrating strong leadership capabilities in managing teams and projects.
• 4+ years experience managing people.
• Proven experience designing, installing, and testing IT systems.
• Proven experience administering LabWare LIMS and Waters Empower applications.
• Pharmaceutical experience is required.
• Proven experience working and/or managing IT projects.
• Strong knowledge of operating and maintaining software in regulated environments; working knowledge of GxP/CSV, GAMP, cGMP, ALCOA+.
• Familiarity with ITIL/ITSM frameworks and service operations.
• Excellent analytical, troubleshooting, and problem-solving skills with a drive for simplification and continuous improvement.
• Exceptional communication skills and fluency in English; ability to influence and collaborate across functions and sites.
• High sense of responsibility, quality mindset, and ability to work autonomously on shared goals.
• Willingness to learn and share knowledge; ability to develop and transfer technical expertise to peers and business users.

Nice To Haves

• Experience with investigations and change management.
• Experience in pharmaceutical/biological manufacturing operations.
• Experience leading others in a pharmaceutical/biological manufacturing facility.
• Additional relevant certifications (e.g., LabWare LIMS or Waters Empower Administration).
• Experience working in QC and QA processes.

Responsibilities

• Lead operations for LabWare LIMS and Waters Empower to ensure reliability, availability, security, and compliance (GxP/CSV, ALCOA+, cGMP).
• Provide timely, expert second-level support; anticipate customer needs and maintain a robust knowledge base for first-level support.
• Own incident, problem, change, configuration, and release management under ITIL/ITSM; document and refine IT processes for efficiency and audit readiness.
• Plan and execute upgrades and patches using risk-based validation approaches; approve validation and IT QMS documentation.
• Manage or contribute to projects (scope, schedule, budget) using best-practice project management.
• Serve as primary site liaison to vendors (LabWare, Waters); manage SLAs, coordinate updates, and negotiate priorities that meet compliance and business needs.
• Establish and monitor KPIs to drive performance and continuous improvement; report status and risks to senior leadership.
• Lead and mentor up to 3 direct reports; foster a collaborative, high-performance culture and standardize best practices across sites where applicable.
• Partner with QC, QA/ITQ, CSV/Validation, Cybersecurity, Manufacturing, and Global IT to align releases, validation scope, and change planning.
• Represent QC IT in audits/inspections; provide authoritative responses and evidence.
• Support additional QC applications added to the portfolio as needed.

Benefits

• Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions.
• In addition, we offer an industry leading 401(k)savings plan, insurance coverage, employee assistance programs and various wellness incentives.
• We support life-work balance with paid vacation time, sick time, and company holidays.
• Explore a supportive environment that enriches both your personal and professional growth!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level