Sr System Engineer- MSAT Systems
# Sr System Engineer- MSAT Systems **FujiFilm** · Morrisville, PA · `On-site` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Indeed* --- ### About the Role 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. As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United St ates.
Наблюдалась 2026-09-15, впервые 2026-09-15, источник — Indeed.