Job Description
Job Description:
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. Key Responsibilities:
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 Required Qualifications:
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 Preferred Qualifications:
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
