Senior GxP Lab Systems Administrator

Replimune

Kansas City (MO)

On-site

USD 110,000 - 140,000

Full time

11 days ago

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Job summary

Replimune seeks a Laboratory GxP Systems Administrator to manage and secure laboratory computerized systems in a regulated environment. The role interfaces with QA, IT, and vendors to maintain validated state, compliance, and uptime.

Based in Milton Park with a 5-day on-site expectation, you will oversee changes, audits, and system lifecycle activities while championing data integrity and cybersecurity across the lab ecosystem.

Qualifications

  • Minimum 5-8 years of experience administering computerized systems in a regulated GxP environment.
  • Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ and Windows/Active Directory environments.
  • Experience with change control, deviations, CAPAs, and quality management systems.
  • Excellent technical writing, communication, and cross-functional collaboration skills.

Responsibilities

  • Administer laboratory computerized systems, including user access, configuration, workflows, and reporting.
  • Maintain inventories, backups, and lifecycle documentation.
  • Coordinate software installations, upgrades, and maintenance with IT and vendors.
  • Support system reliability, cybersecurity, data integrity, and disaster recovery.

Skills

GxP systems
Windows AD
Regulatory compliance
Change control
CAPA
Documentation
Problem solving

Education

Bachelor's degree in Life Sciences
Advanced degree desirable

Tools

viewLinc
Empower
SoftMax Pro GxP
LIMS
QA documentation tools

Job description

Replimune seeks a Laboratory GxP Systems Administrator to manage and secure laboratory computerized systems in a regulated environment. The role interfaces with QA, IT, and vendors to maintain validated state, compliance, and uptime.

Based in Milton Park with a 5-day on-site expectation, you will oversee changes, audits, and system lifecycle activities while championing data integrity and cybersecurity across the lab ecosystem.

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