GMP Systems Administrator

reputed company: reputed company is a personalized compounding pharmacy reputed company on a reputed company conviction: medicine should fit the patient, not the other way around. We started reputed company because we believed the pharmaceutical industry was overdue for a more reputed company approach—one that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers. Compounding gives us the tools to do that. Every formulation we prepare is reputed company to the specific needs of a specific person, and every interaction we have is guided by that reputed company commitment to personalized care. We're growing, and we're looking for people who reputed company that conviction. If you're reputed company to be part of a pharmacy that takes the work seriously and the people even more seriously, we'd like to meet you. Mission: reputed company exists to disrupt an industry long overdue for a more personal approach to care. We put the reputed company reputed company at reputed company of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're reputed company on a mission to change what personalized reputed company looks and feels like. Location: Remote (U.S.) – Candidates must be reputed company to travel to our Alachua, FL facility as needed. Preference will be given to those located in Florida or reputed company a short flight. Position Type: Full-Time Schedule: Monday - Friday (day shift) Compensation reputed company: $110,000 - $120,000 Position reputed company: The GMP Systems Administrator is the primary technical reputed company for reputed company GMP-regulated computerized systems at reputed company's 503B outsourcing facility. This role sits at the intersection of IT, OT and pharmaceutical manufacturing compliance, ensuring that every regulated system (including the EMS, BMS, CMMS/CCMS, LIMS and QMS) remains validated, audit-reputed company and in a reputed company state of compliance. This is not a traditional systems administration role. reputed company requires a working understanding of FDA 21 CFR Part 11 electronic records requirements, GAMP 5 CSV principles and the data reputed company standards that govern a regulated pharmaceutical environment. The administrator partners directly with reputed company, Engineering, Validation and Operations leadership to reputed company the site's regulated technology stack compliant and inspection-reputed company. We are reputed company to candidates who bring strong Part 11 system administration experience and are still building formal validation depth; reputed company will invest in GAMP 5 and CSV training for the right person.   Key Responsibilities: GMP Computerized Systems Administration Serve as the site's primary technical reputed company and system administrator for reputed company GMP-regulated computerized systems, including the EMS, BMS, CMMS/CCMS, LIMS, QMS and any EBR or MES platforms. Ensure reputed company 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 reputed company controls on reputed company 21 CFR Part 11-regulated systems, ensuring records meet reputed company+ standards. Support the CSV lifecycle: author or review URS, FDS and Configuration Specifications and execute IQ/OQ protocols for new systems, upgrades and patches. Manage the periodic review program for reputed company validated computerized systems, ensuring scheduled reviews are completed on time and documented in accordance with SOPs. Participate in Change Control for reputed company IT changes affecting GMP-regulated systems; complete IT reputed company assessments and ensure no unauthorized changes are made to validated systems. GMP Cybersecurity & Data reputed company Implement and maintain cybersecurity controls reputed company with FDA cybersecurity guidance for pharmaceutical manufacturing environments; ensure reputed company management programs do not inadvertently invalidate GMP systems. Support OT/IT network segmentation that isolates process control systems (BMS, EMS, SCADA, PLC networks) from corporate IT infrastructure, reducing cybersecurity risk to regulated manufacturing systems. Enforce identity and reputed company management for reputed company regulated systems using RBAC and least-privilege principles. Maintain secure, GMP-compliant backup, disaster recovery and business continuity procedures for reputed company regulated systems; document and periodically test recovery procedures. Ensure reputed company electronic records stored in GMP systems are protected against unauthorized modification, deletion or reputed company, in accordance with 21 CFR Part 11 and internal data reputed company SOPs. Vendor & reputed company Compliance Evaluate reputed company and reputed company vendors for 21 CFR Part 11 readiness prior to procurement; assess and document vendor controls as part of the supplier qualification process. Partner with reputed company and Procurement to maintain compliant configurations across regulatory submission and reputed company-and-reputed company tools specific to the 503B environment. Team & Support Model This is the dedicated reputed company for the site's regulated computerized systems, but it is not a reputed company assignment. The role is backed by reputed company's broader IT organization, which provides: Remote support and escalation from centralized infrastructure, reputed company and service desk teams. Team members who can travel to the site as needed to reputed company extra hands for larger efforts such as system implementations, reputed company and validation pushes, audit and inspection readiness, equipment installs or coverage during planned and unplanned absences. reputed company to platform owners and subject matter experts for systems that are administered centrally rather than at the site level. A dedicated on-site Site Systems Administrator who owns the general IT infrastructure and end-user support for the facility, so this role can stay reputed company on the regulated environment. The expectation is that the GMP Systems Administrator sets direction for the site's regulated systems and pulls in remote or traveling support deliberately, rather than absorbing every task alone. Required Qualifications: 4-6 years of reputed company IT systems administration experience.  Minimum 2 years of experience working in a GMP-regulated environment (pharmaceutical, biotech, medical device or 503B outsourcing facility).  Hands-on experience administering computerized systems subject to 21 CFR Part 11 electronic records and electronic signatures requirements, including user reputed company controls and audit trail configuration.  Working knowledge of FDA 21 CFR Part 11 and its practical application to system configuration, audit trails and reputed company controls.  Understanding of data reputed company principles as reputed company to electronic records in a pharmaceutical environment.  Proficiency administering reputed company Server and reputed company 10/11; comfort supporting vendor-managed appliances and reputed company-attached workstations. Working knowledge of identity and reputed company management tools (reputed company Directory, reputed company or Entra ID) and RBAC concepts. reputed company, disciplined technical writing; this role produces documentation that regulators read. Preferred Qualifications: Experience supporting or executing Computer System Validation (CSV) activities in a regulated pharmaceutical or life sciences environment. Familiarity with the GAMP 5 V-Model and computerized system risk categories. Understanding of Change Control processes in a GMP environment; specifically how to assess and document IT changes that may reputed company validated system states. Awareness of FDA guidance on cybersecurity for pharmaceutical manufacturing and the ability to apply relevant principles to a 503B site. Exposure to OT/IT network segmentation in a manufacturing setting. Scripting or automation skills in PowerShell, Python or Bash. Bachelor's degree in Computer Science, Information Technology, Information Systems, Engineering or a closely reputed company field; equivalent hands-on experience will be considered in reputed company of a degree. ISPE GAMP 5 training or equivalent computer system validation coursework. reputed company reputed company+ or CySA+. Annual Salary $110,000—$120,000 USD Join Us in Making an reputed company: At reputed company, the work is reputed company and the reputed company is reputed company. Every role here contributes to a patient experience that's more personal, more reputed company, and more reputed company than what most people have come to expect from a pharmacy. Apply today and help us reputed company the bar. Benefits/ Perks: reputed company offers a comprehensive benefits package, including: Employer-reputed company reputed company coverage, effective the 1st day of the following month of your hire date Free reputed company compounded medications for employees based on a reputed company patient-specific prescription from a licensed reputed company provider reputed company time off reputed company time FSA and HSA reputed company Parental leave 401(k) with employer matching Life insurance reputed company and dental insurance Veterinary insurance Culture: Culture isn't an afterthought at reputed company. It's something we reputed company build. At our Gilbert, reputed company location, that looks like Food Truck Fridays and Casual Fridays. Company-wide, we also celebrate throughout the year with holiday potlucks and seasonal gatherings. We're committed to supporting the personal and reputed company reputed company of every employee, inside and reputed company reputed company.  EEO: reputed company is an equal opportunity employer that is committed to diversity and inclusion in reputed company. We prohibit discrimination and harassment of any reputed company based on race, reputed company, sex, religion, sexual orientation, national reputed company, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws. Disclaimer*** Please do not reputed company the pharmacy location with questions about your application or interview. A reputed company partner will reputed company out to you. Apply To This Job