GxP Systems Admin

Job Title

GxP Systems Admin

Lexington, MA

Long Term

We are seeking a GxP Systems Admin to support and maintain regulated manufacturing, laboratory, and automation systems within a pharmaceutical or biotechnology environment. This role will be responsible for system administration, user support, compliance activities, troubleshooting, and ensuring systems remain in a validated and compliant state.

• Administer and support GxP-regulated computerized systems across manufacturing, laboratory, and automation environments.
• Manage user accounts, system access, permissions, and security controls.
• Perform system maintenance, monitoring, troubleshooting, backups, and routine health checks.
• Support periodic system reviews, audits, inspections, and compliance activities.
• Maintain system administration records, logs, and documentation.
• Participate in change control, deviation investigations, and CAPA activities.
• Ensure compliance with data integrity principles, CSV requirements, and regulatory standards.
• Collaborate with Quality, Manufacturing, IT, Validation, and Engineering teams to support business operations.

• Bachelor's Degree in Information Technology, Engineering, Life Sciences, Computer Science, or a related field.
• 4+ years of experience administering GxP-regulated computerized systems in pharmaceutical, biotechnology, or life sciences environments.
• Experience supporting manufacturing, laboratory, or automation applications.
• Working knowledge of DCS/SCADA Systems such as DeltaV, Factory Talk, or Metasys.
• Experience with Historian Systems (PI) and laboratory applications including LabX, Unicorn, Sartocheck, Nova Biomass, or Thin Manager.
• Strong understanding of Data Integrity principles (ALCOA+), CSV, and Change Control & CAPA processes (Track Wise).
• Experience managing user access, system security, troubleshooting, backups, and routine system maintenance activities.
• Strong troubleshooting, documentation, communication, and problem-solving skills.

Full-time