GMP Systems Administrator

Strive Compounding Pharmacy

GMP Systems Administrator owning validated computerized systems, cybersecurity and data integrity for Strive Pharmacy’s 503B compounding facility. Maintaining inspection-ready technology across regulated pharmaceutical operations.

Posted 8/5/2026full-timeAlachua • Florida • 🇺🇸 United StatesJuniorMid-Level💰 $110,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing GMP-regulated computerized systems, ensuring compliance with 21 CFR Part 11 and GAMP 5 guidelines. Proficient in system administration, cybersecurity controls, and technical documentation within a pharmaceutical or biotech environment.

Highest-signal resume keywords

GMP-Regulated Systems Administration21 CFR Part 11 ComplianceGAMP 5 GuidelinesWindows Server AdministrationActive Directory Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GMP-Regulated Systems Administration21 CFR Part 11 ComplianceGAMP 5 GuidelinesWindows Server AdministrationPowerShellPythonBashCSV Lifecycle ManagementData Integrity PrinciplesTechnical Writing

Soft Skills

Clear Technical WritingAbility to Travel

Tools & Technologies

EMSBMSCMMSLIMSQMSEBRMESSCADAPLCVendor-Managed Appliances

Certifications & Qualifications

CompTIA Security+CySA+ISPE GAMP 5 Training

Industry Keywords

GMPPharmaceuticalBiotechMedical Device503B OutsourcingAudit TrailsElectronic SignaturesChange ControlCybersecurityRBAC

Tech Stack

Tools & technologies

Cyber SecurityPython

About the role

Key responsibilities & impact

Serve as the primary technical owner and system administrator for all GMP-regulated computerized systems, including EMS, BMS, CMMS/CCMS, LIMS, QMS, EBR and MES platforms
Maintain regulated systems in a validated state in accordance with GAMP 5 guidelines
Manage audit trails, electronic signatures and user access controls to meet 21 CFR Part 11 and ALCOA+ standards
Support the CSV lifecycle by authoring or reviewing URS, FDS and Configuration Specifications and executing IQ/OQ protocols
Manage periodic reviews of validated computerized systems
Participate in Change Control and complete IT impact assessments for GMP-regulated system changes
Implement cybersecurity controls and maintain patch management programs
Support OT/IT network segmentation for BMS, EMS, SCADA and PLC networks
Enforce RBAC and least-privilege access management
Maintain and test GMP-compliant backup, disaster recovery and business continuity procedures
Protect electronic records from unauthorized modification, deletion or access
Evaluate SaaS and enterprise vendors for 21 CFR Part 11 readiness
Partner with Quality and Procurement on compliant configurations for regulatory submission and track-and-trace tools
Set direction for regulated systems and coordinate remote, traveling, infrastructure, security and service desk support

Requirements

What you’ll need

4–6 years of progressive IT systems administration experience
Minimum 2 years of experience in a GMP-regulated environment such as pharmaceutical, biotech, medical device or 503B outsourcing
Hands-on administration of computerized systems subject to 21 CFR Part 11 electronic records and electronic signatures requirements
Working knowledge of FDA 21 CFR Part 11 and its application to system configuration, audit trails and access controls
Understanding of data integrity principles for electronic records in pharmaceutical environments
Proficiency administering Windows Server and Windows 10/11
Comfort supporting vendor-managed appliances and instrument-attached workstations
Working knowledge of Active Directory, Okta or Entra ID and RBAC concepts
Clear, disciplined technical writing
Ability to travel to the Alachua, Florida facility as needed
Preferred: CSV experience, GAMP 5 V-Model familiarity, GMP Change Control, FDA pharmaceutical cybersecurity guidance, OT/IT network segmentation, PowerShell, Python or Bash, ISPE GAMP 5 training or equivalent CSV coursework, CompTIA Security+ or CySA+

Benefits

Comp & perks

Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date
Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider
Paid time off
Sick time
FSA and HSA options
Parental leave
401(k) with employer matching
Life insurance
Vision and dental insurance
Veterinary insurance
Holiday potlucks and seasonal gatherings
Personal and professional growth support