Systems Administrator - Alachua Onsite

GMP Computerized Systems Administration

• Serve as the site’s primary technical owner and system administrator for all GMP-regulated computerized systems, including the EMS, BMS, CMMS/CCMS, LIMS, QMS and any EBR or MES platforms.
• Ensure all regulated systems maintain a Validated State in accordance with GAMP 5 guidelines; coordinate with Validation on system categorization and risk-based validation approaches.
• Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA+ standards.
• Support the CSV lifecycle: author or review URS, FDS, Configuration Specifications, and execute IQ/OQ protocols for new systems, upgrades, and patches.
• Manage the Periodic Review program for all validated computerized systems, ensuring scheduled reviews are completed on time and documented in accordance with SOPs.
• Participate in Change Control for all IT changes affecting GMP-regulated systems; complete IT impact assessments and ensure no unauthorized changes are made to validated systems.

Site IT Infrastructure & Network Management

• Support the on-site network architecture including LAN/WAN, VLANs, network segmentation between OT and IT environments, firewalls, DNS, DHCP, QoS, and ZTNA.
• Support and maintain networks; ensure network topology supports both office and manufacturing floor connectivity without compromising GMP system integrity.
• Support OT/IT network segmentation to isolate process control systems (BMS, EMS, SCADA, PLC networks) from corporate IT infrastructure, reducing cybersecurity risk to regulated manufacturing systems.

GMP Cybersecurity & Data Integrity

• Implement and maintain cybersecurity controls aligned with FDA cybersecurity guidance for pharmaceutical manufacturing environments; ensure patch management programs do not inadvertently invalidate GMP systems.
• Manage identity and access management (IAM) for all site systems using tools such as Okta, Windows Active Directory or Azure Active Directory; enforce RBAC and least-privilege principles across all GMP and non-GMP systems.
• Maintain secure, GMP-compliant BDR procedures for all regulated systems; document and periodically test recovery procedures as part of the BCP.
• Ensure all electronic records stored in GMP systems are protected against unauthorized modification, deletion, or access, in accordance with 21 CFR Part 11 and internal data integrity SOPs.

Cloud Infrastructure & SaaS Platform Management

• Administer and optimize cloud infrastructure systems used to support operations.
• Manage the full portfolio of SaaS and enterprise platforms including Google Workspace, Okta, pharmacy management systems, ERP, and any 503B-specific regulatory submission or track-and-trace tools.
• Support Evaluation of SaaS vendors for 21 CFR Part 11 readiness prior to procurement; assess and document vendor controls as part of the supplier qualification process.

End-User Support, Training & Onboarding

• Serve as the primary on-site IT support resource for all manufacturing, quality, engineering, and administrative staff.
• Provision and manage workstations, laptops, tablets, and mobile devices across macOS, Windows, and Linux environments using MDM tools such as Microsoft Intune, Addigy, or NinjaOne.
• Develop and deliver GMP-compliant IT system training for new employees.
• Maintain an accurate IT asset inventory covering all hardware, software licenses, and SaaS subscriptions; manage renewal cycles and ensure license compliance.

Automation, Scripting & Operational Efficiency

• Develop and maintain automation scripts to streamline IT operations.
• Utilize RMM/MDM platforms such as ConnectWise Automate, ConnectWise Control, NinjaOne, Addigy, or Microsoft Intune for centralized endpoint management and remote support.
• Identify and implement continuous improvement opportunities within IT operations to reduce manual effort, improve system reliability, and support the site’s RTO and long-term growth objectives.

Required Qualifications

• Demonstrated experience in a regulated GMP/healthcare IT environment.
• 5–8 years of progressive IT systems administration experience.
• Minimum 2–3 years of experience working in a GMP-regulated environment (pharmaceutical, biotech, medical device, or 503B outsourcing facility).
• Demonstrated hands-on experience administering computerized systems subject to 21 CFR Part 11 electronic records and electronic signatures requirements.
• Experience supporting or executing Computer System Validation (CSV) activities in a regulated pharmaceutical or life sciences environment.
• Prior experience as the primary or sole on-site IT resource for a manufacturing facility is a significant plus.
• Working knowledge of FDA 21 CFR Part 11 and its practical application to system configuration, audit trails, and access controls.
• Familiarity with GAMP 5 V-Model and computerized system risk categories.
• Understanding of data integrity principles as applied to electronic records in a pharmaceutical environment.
• Awareness of FDA guidance on cybersecurity for medical devices and pharmaceutical manufacturing, and ability to apply relevant principles to a 503B site.
• Understanding of Change Control processes in a GMP environment — specifically how to assess and document IT changes that may impact validated system states.
• Proficiency in managing Windows Server, Windows 10/11, macOS, and Linux operating systems in a mixed enterprise environment.
• Strong knowledge of networking protocols, TCP/IP, VLANs, firewall management, DNS/DHCP, and OT/IT network segmentation; experience with Fortinet, Arista, OPNsense, FreeBSD and/or Palo Alto preferred.
• Experience with virtualization platforms (VMware vSphere/ESXi, Proxmox) and server hardware management.
• Proficiency with identity and access management tools (Okta, Azure AD/Entra ID, Active Directory).
• Experience with endpoint management platforms (Microsoft Intune, NinjaOne, ConnectWise, or Addigy).
• Scripting/automation skills in one or more of: PowerShell, Python, Bash. Clojure, Elixir or Go experience is a plus.