The Senior Infrastructure Specialist is responsible for designing, implementing, and supporting core infrastructure services across on-premises and cloud environments with a strong focus on networking, compute, storage, virtualization, and application hosting. This role ensures that infrastructure supporting GxP systems meets compliance requirements such as GMP, 21 CFR Part 11, Annex 11, Data Integrity (ALCOA+), and cybersecurity frameworks. The specialist partners closely with IT Core Services, Lab IT, Manufacturing/Quality IT, QA, and external auditors to maintain secure, resilient, validated, and audit-ready infrastructure.

At FUJIFILM Cellular Dynamics, we’re unlocking the power of human cells to change lives. Using revolutionary induced pluripotent stem cell (iPSC) technology, we drive advancements in drug discovery, disease modeling, cell therapy, research tools, and cell therapy manufacturing. Our mission is deeply meaningful, and we’re looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics, you’ll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If you’re ready to do work that makes a real impact and propels healthcare forward, this is your chance to be part of something extraordinary for science, patients, and yourself.

Our headquarters is in Madison, Wisconsin, a dynamic city celebrated for its lakes, parks, cultural richness, biotech leadership, and access to world-class academia.

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

Roles & Responsibilities

Infrastructure Architecture & Operations

• Design, deploy, and maintain network, server, storage, and virtualization platforms supporting enterprise and GxP workloads.
• Administer Windows and Linux servers, Active Directory, domain services, group policies, and identity integrations.
• Maintain virtualization platforms (VMware, Hyper-V) including resource allocation, HA/DRS, snapshots, capacity planning, and performance monitoring.
• Manage enterprise network components: firewalls, switches, routers, wireless infrastructure, VLANs, VPNs, SD-WAN, and security zoning aligned with GxP network segregation.
• Administer infrastructure required for regulated application hosting (PAS-X, LabWare, LIMS instruments, historian systems, Veeva connectors, analytics platforms).
• Provide subject-matter expertise for cloud infrastructure (Azure, AWS, SaaS) including IaaS, PaaS, identity, access, logging, and compliance settings.

Compliance, Validation & Documentation

• Ensure infrastructure supporting regulated systems complies with:
  • 21 CFR Part 11
  • EU Annex 11
  • GMP/GLP requirements
  • Data Integrity (ALCOA+)
  • Company Quality Systems
• Participate in System Development Life Cycle (SDLC) activities including URS, risk assessments, validation planning, IQ/OQ, and periodic review.
• Develop and maintain SOPs, Work Instructions, Engineering Documentation, System Architecture Diagrams, and change control records.
• Support internal and external audits (FDA, EMA, PMDA, corporate QA).
• Ensure infrastructure hardening, logging, time synchronization, backup/restore, disaster recovery, and access controls meet regulatory expectations.

Application & Cloud Hosting Support

• Administer enterprise and GxP application hosting environments including IIS, SQL/Oracle databases, middleware, SFTP exchanges, and API gateways.
• Support cloud SaaS/PaaS applications including proper identity governance, security configurations, audit logging, retention, and compliance documentation.
• Work with system owners and SMEs to define and maintain infrastructure qualification.
• Ensure that patching, system upgrades, and changes follow robust change control and do not impact validated state.

Security & Cyber Governance

• Implement and maintain controls aligned to NIST, CIS Benchmarks, ISO 27001, and internal cybersecurity policies.
• Manage privileged access (PAM), network segmentation, least-privilege configuration, and secure remote access tools.
• Ensure system monitoring, threat detection, vulnerability scanning, event retention, and incident response processes are in place.
• Partner with Security teams on risk assessments, remediation, and continuous improvement.

Collaboration & Leadership

• Work as a senior technical partner with Core IT Services, Lab IT, Manufacturing/Quality IT, Facility Engineering, QA, and vendors.
• Provide escalation support and mentor junior staff in infrastructure, compliance, and troubleshooting.
• Participate in project planning, solution design, vendor selection, implementation, and lifecycle management.
• Communicate complex infrastructure and compliance topics clearly to technical and non-technical stakeholders.

Qualifications

Required

• Bachelor’s degree in Information Technology, Computer Science, or related field (or equivalent experience).
• 8+ years of experience in enterprise infrastructure (network, server, cloud, virtualization).
• Hands-on experience in:
• VMware or Hyper-V
• Windows/Linux server administration
• Enterprise networking (Cisco, Fortinet, Palo Alto, Meraki)
• Azure/AWS cloud fundamentals
• Identity management (AD, Azure AD/Entra ID)
• Experience supporting GxP systems in biotech/pharma, including understanding of validation and data integrity expectations.
• Strong understanding of 21 CFR Part 11, audit trails, access controls, electronic records, and electronic signatures.
• Experience with change control, CAPA, deviation management, and SDLC documentation.
• Ability to work in a fast-paced, highly regulated, manufacturing/lab environment.

Preferred

• Experience with infrastructure supporting systems such as PAS-X, LabWare, LIMS equipment PCs, Manufacturing Historians, OT networks.
• Certifications (one or more):
• CCNA/CCNP
• Microsoft/Azure Administrator
• VMware VCP
• CISSP, Security+, or equivalent
• Experience with hybrid cloud, automation (PowerShell, Ansible), and Infrastructure-as-Code.
• Experience in biotech, cell therapy, iPSC, pharma manufacturing, or regulated operations.

Success Factors

• Operates effectively in audit-ready environments.
• Balances technical excellence with compliance discipline.
• Strong documentation and communication.
• Proactive in security, stability, and lifecycle management.
• Able to influence cross-functional teams and drive continuous improvement.

Fujifilm is committed to 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.

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 (fcdi-hr@fujifilm.com).