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.
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; escalate 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.
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.
