Senior IT Infrastructure Specialist

Fujifilm

Job Location:

Madison, OH - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

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.

Company Overview

At FUJIFILM Cellular Dynamics were 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 were looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics youll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If youre 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 70000 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: Description

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

Bachelors 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.

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 ().

Required Experience:

Senior IC

Position OverviewThe 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 infra...