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4 дня назад

Senior IT GXP Systems Specialist (GxP)

54 - 60$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior IT GXP Systems Specialist (GxP): Managing and supporting validated computerized systems for laboratories, manufacturing, and regulatory operations with an accent on system administration, computer system validation, data integrity, and 21 CFR Part 11 compliance. Focus on implementing and maintaining GxP software and equipment, troubleshooting incidents, coordinating upgrades, and ensuring reliable 24x7 operational support.

Location: Onsite in El Segundo, California, United States. Monday–Friday during standard business hours, with on-call rotation and occasional after-hours emergency support.

Salary: $54.52–$60.57 per hour, depending on qualifications, experience, and geographic location. Eligible for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded biotechnology company developing cell and immunotherapy products, vaccines, and treatments for cancer and infectious diseases.

What you will do

  • Implement, administer, maintain, and support GxP software and computerized systems for laboratory equipment, manufacturing, and regulatory operations.
  • Provide technical leadership for system deployments, upgrades, maintenance, and support across multiple company sites.
  • Create and maintain system documentation, specifications, administrative and security SOPs, and validation test scripts.
  • Manage incident tickets, troubleshoot systems, and perform periodic system assessments.
  • Define user roles, privileges, and data security controls to protect data integrity.
  • Coordinate vendors, business partners, and cross-functional stakeholders while maintaining a service catalog for IT GxP operations.

Requirements

  • Bachelor’s degree in IT, Computer Science, Engineering, or a related field plus 4+ years of hands-on systems administration experience in the pharmaceutical or related industry; alternatively, a high school diploma plus 8+ years of relevant experience.
  • Experience supporting end users, servers, applications, storage, and networking.
  • Strong knowledge of Windows operating systems, TCP/IP, DNS, DHCP, VLANs, wireless access points, IP addresses, group policies, and user/group security management.
  • Working knowledge of FDA cGMP and cGLP regulations, including 21 CFR Part 11, and experience with validated systems and CSV processes.
  • Strong incident management, problem-solving, troubleshooting, documentation, communication, and business partnering skills.
  • Ability to work onsite in a laboratory environment, wear required PPE, lift and carry up to 20 pounds, and participate in an on-call rotation.

Nice to have

  • 1+ year of IT support experience in a GxP environment.

Culture & Benefits

  • Collaborative work across R&D, Quality Control, Engineering, Manufacturing, and other company functions.
  • Professional development opportunities within a growing biopharmaceutical company.
  • Medical, dental, and vision plan options, health and financial wellness programs, and an Employee Assistance Program.
  • 401(k) retirement plan with company match, flexible spending accounts, life and disability coverage, and paid time off.
  • Additional benefits include education savings, legal services, identity theft protection, pet insurance, employee discounts, rewards, and perks.

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