Manufacturing Science and Technology (MSAT) Applications Administrator
FUJIFILM Biotechnologies · Holly Springs, NC · 3 wk ago
Information TechnologyFull-time
About the role
This position is on-site at our Holly Springs, North Carolina facility.
Responsibilities
- 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
- 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
- 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
Requirements
- Bachelor’s degree in Computer Science, Engineering, Scientific field, or equivalent practical experience
- 5+ years in MSAT systems administration or historian applications including 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
Qualifications
- Nice to have: 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
Skills
- Hands-on experience with MSAT systems administration
Benefits
- Comprehensive benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions
- Industry leading 401(k)savings plan
- Insurance coverage
- Employee assistance programs
- Variety of wellness incentives
- Paid vacation time, sick time, and company holidays
Pay
TBD
Schedule
On-site at Holly Springs, North Carolina