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GMP Systems Administrator

3 weeks ago
United States
Full-time
Senior
Operations Manager
Cybersecurity
Active Directory Bash Cybersecurity PowerShell Python Windows Server
Apply Now
Strive Pharmacy

Strive Pharmacy

Strive Pharmacy is a premier specialty compounding pharmacy with locations across the US. We customize medications to meet individual needs, health conditions, and wellness goals. Our focus is on providing comprehensive health solutions for patients, f...

Health Care Providers & Services
11-50
Founded 2018
View All Jobs 12

Description

  • Serve as the primary technical owner for GMP-regulated computerized systems, including EMS, BMS, CMMS/CCMS, LIMS, QMS, EBR and MES platforms.
  • Maintain a validated state for regulated systems and coordinate validation strategy with the Validation team.
  • Manage audit trails, electronic signatures and user access controls for 21 CFR Part 11 systems.
  • Author or review CSV documentation such as URS, FDS, configuration specifications and IQ/OQ protocols.
  • Run the periodic review program for validated systems and ensure documentation is completed on schedule.
  • Participate in change control for IT changes affecting GMP systems and complete impact assessments.
  • Implement cybersecurity and data integrity controls for regulated manufacturing systems.
  • Support OT/IT network segmentation, backup, disaster recovery and business continuity procedures.
  • Evaluate SaaS and enterprise vendors for Part 11 readiness and support supplier qualification.
  • Partner with Quality, Engineering, Procurement and Operations to keep regulated technology compliant and inspection-ready.

Requirements

  • 4-6 years of progressive IT systems administration experience.
  • At least 2 years of experience in a GMP-regulated environment such as pharmaceutical, biotech, medical device or a 503B outsourcing facility.
  • Hands-on experience administering systems subject to 21 CFR Part 11 electronic records and signatures requirements.
  • Working knowledge of FDA 21 CFR Part 11, data integrity principles and practical system configuration requirements.
  • Proficiency with Windows Server and Windows 10/11, including support for vendor-managed appliances and instrument-attached workstations.
  • Working knowledge of identity and access management tools such as Active Directory, Okta or Entra ID and RBAC concepts.
  • Clear, disciplined technical writing skills for regulator-facing documentation.
  • Experience supporting or executing Computer System Validation activities is preferred.
  • Familiarity with the GAMP 5 V-Model and computerized system risk categories is preferred.
  • Bachelor's degree in Computer Science, Information Technology, Information Systems, Engineering or a related field, or equivalent hands-on experience.
  • ISPE GAMP 5 training or equivalent CSV coursework is preferred.
  • CompTIA Security+ or CySA+ is preferred.

Benefits

  • $110,000-$120,000 annual salary.
  • Employer-paid healthcare coverage effective the first day of the following month after hire.
  • Free Strive compounded medications for employees with a valid patient-specific prescription.
  • Paid time off and sick time.
  • FSA and HSA options.
  • Parental leave.
  • 401(k) with employer matching.
  • Life, vision and dental insurance, plus veterinary insurance.

Interested in this position?

Apply directly on the company website

Apply Now

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