GxP Systems Engineer

We are seeking an experienced GxP Systems Engineer to support the design, deployment, integration, and management of Digital Quality Automation Systems and laboratory instrumentation within GMP-regulated environments. The ideal candidate will have strong experience working with laboratory automation systems, analytical instruments, system integrations, validation, and GxP compliance.

• Support implementation, optimization, maintenance, and upgrades of Digital Quality Automation Systems such as Hamilton Venus, Scitara DLX, and analytical laboratory instrumentation
• Collaborate with business analysts, software engineers, automation teams, and digital stakeholders throughout the system lifecycle
• Translate system, equipment, and data integration requirements into scalable digital lab solutions within GMP environments
• Support integration of laboratory systems with connected digital platforms, robotics, automation systems, and future AI initiatives
• Manage and support change controls, SOPs, work instructions, KB articles, and regulatory documentation
• Ensure systems comply with GxP, GAMP, and FDA regulatory requirements
• Participate in system validation, implementation, maintenance, and inspection readiness activities
• Support troubleshooting, optimization, and continuous improvement of laboratory digital workflows
• Collaborate with cross-functional teams including Quality, Validation, IT, and Laboratory Operations
• Participate in internal and external audits as Digital Quality Systems SME

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field
• 5+ years of experience supporting life sciences analytical instruments and laboratory systems within GMP environments
• Experience with Digital Quality Automation Systems such as Hamilton Venus, Scitara DLX, or similar laboratory automation platforms
• Strong understanding of laboratory systems integration, digital workflows, and data integrity requirements
• Experience with GxP, GAMP, FDA 21 CFR Part 11, and compliance regulations
• Experience supporting cloud-hosted and on-prem laboratory systems integration
• Strong troubleshooting, documentation, and communication skills

• Experience with Linux/Ubuntu environments
• Experience with robotics, automation, and connected instrument platforms
• Experience supporting AI-enabled laboratory initiatives
• Strong understanding of laboratory quality management workflows and analytical instrumentation