Senior System Engineer - MSAT Systems

FUJIFILM Holdings America Corporation; Holly Springs (NC); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company contributions

Paid vacation, holidays

Job summary

FUJIFILM Biotechnologies seeks a Senior System Engineer — MSAT Applications to own and advance the platforms enabling real-time process understanding and data-driven decisions. You will support SIMCA-online, Statistica Server, PAT, and related integrations across manufacturing and development.

The role emphasizes cGxP compliance, data integrity, validation, and audit readiness, with cross-site collaboration and ITIL-style incident/change management.

Qualifications

• Bachelor’s degree in Computer Science, IT, Engineering or scientific field.
• 8+ years of relevant experience in Information Technology or Engineering.
• 3+ years’ experience with MSAT-type applications (e.g., SIMCA-online, Statistica, synTQ, AspenTech) or historian apps.

Responsibilities

• Platform ownership and administration of MSAT analytics tools.
• Integrations and data lifecycle management across DCS/SCADA, historians, MES, LIMS/ELN.
• Security, data integrity, validation, and audit readiness (GxP).
• RBAC/ADLP and SSO implementations; vulnerability management and patch cycles.
• Operations support including incident/change management and performance tuning.
• Prepare for audits and inspections; ensure complete records of configurations and changes.

Skills

MSAT applications

Data analytics

ITIL processes

V&V

Troubleshooting

Education

Bachelor’s degree in Computer Science, IT, Engineering

Tools

SIMCA-online

Statistica

OSisoft PI/AVEVA

SQL Server/Oracle

PowerShell

Job description

Position Overview

Build the analytics backbone that powers smarter manufacturing. As FUJIFILM Biotechnologies' Senior System Engineer — MSAT Applications, you will own and evolve the platforms that let our Manufacturing Science & Technology (MSAT) teams see, understand, and control processes in real time. From SIMCA-online and TIBCO Statistica to PAT and historian integrations, you’ll make sure these GxP systems are secure, validated, reliable, and fast—so scientists and engineers can make data-driven decisions that improve yield, reduce deviations, and speed life-changing therapies to patients.

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

Why this role matters

• Turn data into decisions: Your work enables robust multivariate monitoring and real-time analytics that drive right-first-time performance and continuous improvement.
• Protect our license to operate: You’ll embed cGxP, data integrity (ALCOA+), and validation into mission-critical systems—strengthening audit and inspection outcomes.
• Scale impact across sites: By standardizing and integrating MSAT tools across manufacturing and development, you’ll uplift reliability and insight network-wide.

What you’ll do

• Platform ownership
  • Administer and support SIMCA-online, Statistica Server, and PAT platforms.
  • Manage Windows Server instances, services, and dependencies; ensure uptime and capacity planning.
  • Maintain databases (SQL Server/Oracle) for configuration, results storage, and audit trails.
• Integrations and data lifecycle

• • Integrate with DCS/SCADA (e.g., DeltaV), historians (e.g., OSIsoft PI/AVEVA), MES (e.g., Syncade), LIMS/ELN, OPC UA/DA/MQTT gateways, and file/API-based exchanges.
  • Manage data retention, archival, and restoration aligned to corporate data governance policies.

• Compliance, data integrity, and validation

• • Ensure cGxP, ALCOA+, and security requirements across integrations; partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness.

• Security and access control
  • Implement RBAC/least-privilege, AD/LDAP integration, and SSO where applicable.
  • Manage audit trails, e-signatures, certificates, and secure configurations.
  • Coordinate vulnerability management, patching, and endpoint protection aligned with GxP and downtime windows.

• Operations and support
  • Provide tiered support; run incident/problem/change management with root-cause analysis and CAPA.
  • Monitor system health, job queues, connectors, and data flows; tune performance and troubleshoot latency.
  • Coordinate vendor relationships, licenses, and support contracts; plan upgrades and patch cycles.
  • Implement business continuity, backup/restore validation, and disaster recovery testing.
  • Configure systems to meet evolving business requirements.

• Audit and inspection readiness

• • Prepare and support internal/external audits and health authority inspections.

  • Maintain complete, contemporaneous records of configurations, deviations, and changes.

• And other job duties that may be assigned from time to time.

Minimum qualification requirements

• Bachelor’s degree in Computer Science, IT, Engineering, or a scientific field.
• 8+ years of relevant experience in Information Technology or Engineering.
• 3+ years’ experience with MSAT-type applications (e.g., SIMCA-online, Statistica, synTQ, AspenTech) or historian applications.

Preferred requirements

• Experience in manufacturing or process development systems.
• Strong Windows Server/Active Directory administration; scripting (PowerShell); SQL Server/Oracle fundamentals.
• Experience with OSIsoft PI/AVEVA, OPC UA/DA, and DCS/SCADA or MES integrations.
• Proven change/incident/problem management using ITIL practices.

What you’ll bring to thrive

• Fluency in manufacturing data flows and MSAT use cases; ability to translate requirements into robust configurations.
• Hands‑on validation expertise and documentation rigor (CSV mindset) with an eye for audit readiness.
• Strong troubleshooting instincts; performance tuning across integrations, connectors, and data pipelines.
• Clear, proactive communication across MSAT, Engineering, IT, QA/CSV, and vendors; influence without direct authority.
• Judgment to balance speed, compliance, and standardization; elevate risks appropriately.

Scope and collaboration

• Individual contributor with ownership of systems that support manufacturing and process development business units.
• Work cross-functionally with MSAT, Engineering, and IT globally to ensure platforms meet business needs and scale reliably.
• Recognized as a subject‑matter resource for applications within scope; your decisions drive operational reliability and insight.

Work environment

• General office/hybrid; ability to travel to an FLBG site up to once per quarter.
• Global stakeholders and users across time zones.

Your impact from day one

• Keep critical MSAT analytics platforms secure, validated, and available—reducing downtime and deviations.
• Accelerate data-driven process understanding, enabling faster tech transfers, better yields, and stronger compliance.
• Standardize and integrate tools that scale across sites—amplifying value for scientists, engineers, and ultimately, patients.

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!

This is a global position that will support all our FUJIFILM Biotechnologies sites. Benefits and compensation will be governed by the location that you are based from and considered your home site.

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. Theorganisationis committedto beingtransparent about how it collects and uses that dataand to meeting its data protection obligations and may share this as part of the global recruitment process with hiringmanagers in Europe and the United States.

EEO Information

Fujifilm is committedto 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 ([e-mail]).