Systems Administrator - Alachua Onsite

Position Type: Full-Time

Location: Alachua, FL (on-site Monday - Friday day shift)

Salary: $85,000 - $95,000

Travel: up to 25%

 

Position Overview:

The IT Systems Administrator serves as the dedicated, on-site technology leader for Strive Pharmacy’s 503B outsourcing facility in Alachua, Florida. This is a high-impact, hands-on role at the intersection of information technology and pharmaceutical manufacturing compliance. The successful candidate will own the full IT infrastructure stack for the site while simultaneously acting as the primary technical owner for all GMP-regulated computerized systems — including the EMS, BMS, CMMS/CCMS, LIMS, and QMS. 

Unlike a traditional systems administrator role, this position requires a deep understanding of FDA 21 CFR Part 11 electronic records requirements, GAMP 5 CSV principles, and the data integrity standards that govern a regulated pharmaceutical environment. The IT Systems Administrator partners directly with Quality, Engineering, Validation, and Operations leadership to ensure that every computerized system is validated, audit-ready, and operating in a continuous state of compliance. 

 

Key Responsibilities:

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. (Required)
• 5–8 years of progressive IT systems administration experience. (Required) 
• Minimum 2–3 years of experience working in a GMP-regulated environment (pharmaceutical, biotech, medical device, or 503B outsourcing facility). (Required) 
• Demonstrated hands-on experience administering computerized systems subject to 21 CFR Part 11 electronic records and electronic signatures requirements. (Required)
• Experience supporting or executing Computer System Validation (CSV) activities in a regulated pharmaceutical or life sciences environment. (Strongly Preferred) 
• 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. 

 

Preferred Qualifications:

• Bachelor’s degree in Computer Science, Information Technology, Information Systems, Electrical Engineering, or a closely related field
• CompTIA Security+, Network+, or CySA+ 
• Cisco CCNP or equivalent network certification 
• ISPE GAMP 5 training or equivalent computer system validation coursework

 

Work Environment: This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities.