Computer System Validation Csv Jobs in Raleigh, NC

Join a high-impact team enabling data-driven manufacturing and development. As our System Administrator for MSAT applications, you will own, maintain, and continuously improve our analytics and real-time monitoring ecosystem-centered on SIMCA-online, TIBCO Statistica, and Process Analytical Technology (PAT). Your work will ensure our GxP systems are secure, validated, and highly available across global manufacturing and development environments, empowering robust multivariate monitoring, real-time analytics, and confident decision-making.

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

• Platform ownership and reliability
  • Administer and support SIMCA-online, Statistica Server, and PAT platforms
  • Manage Windows Server services, capacity, and uptime; tune performance and troubleshoot latency
  • Maintain SQL Server/Oracle databases for configurations, 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, and OPC UA/DA/MQTT gateways
  • Manage data retention, archival, and restoration aligned to corporate data governance
• Compliance, validation, and data integrity
  • Ensure cGxP compliance, data integrity (ALCOA+), and security across integrations
  • Partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness
• Security and access management
  • Implement RBAC/least-privilege, AD/LDAP integration, and SSO where applicable
  • Manage audit trails, e-signatures, certificates, vulnerability management, and patching within validated-state controls
• Operations and continuous improvement
  • Lead incident/problem/change management; conduct root cause analysis and drive CAPAs
  • Monitor connectors, job queues, and data flows; plan upgrades, patch cycles, and license/vendor management
  • Implement and test backup/restore, business continuity, and disaster recovery
• Audit and inspection readiness
  • Maintain complete and contemporaneous records of configurations, changes, and deviations
  • Support internal/external audits and health authority inspections

• Bachelor's degree in Computer Science, Engineering, Scientific field, or equivalent practical experience
• 5+ years in IT systems administration, with 3+ years supporting MSAT or historian applications
  • Experience with SIMCA-online, TIBCO Statistica, synTQ, AspenTech, and/or historian platforms
• Strong Windows Server and Active Directory administration; PowerShell scripting; SQL Server/Oracle fundamentals
• Experience with OSIsoft PI/AVEVA, OPC UA/DA, DCS/SCADA, MES, LIMS/ELN, and API/file-based integrations
• Practical knowledge of cGxP, data integrity (ALCOA+), Computer Systems Validation (CSV), GAMP 5, and CSA approaches
• Familiarity with ITIL-based change/incident/problem management and service operations

• Background in biopharma manufacturing or process development environments
• Experience designing secure architectures with SSO, certificates, and electronic signatures in validated systems
• Performance tuning, capacity planning, and proactive monitoring for real-time analytics platforms

• Own mission-critical platforms that power process insight and product quality
• Collaborate with global MSAT, Engineering, QA/CSV, and IT experts
• Drive tangible impact across manufacturing and development through modern analytics and PAT
• Grow your expertise in validated, high-availability, and integrated data environments

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!

As part of any recruitment process, FUJIFILM Diosynth 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 States.

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

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. Allresumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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 (fdbglobaltalent@fujifilm.com).