GxP Systems Engineer

We are seeking an experienced GxP Systems Engineer to support the design, deployment, integration, and lifecycle management of advanced digital quality and laboratory automation systems within a GMP-regulated biopharmaceutical environment. The ideal candidate will have strong expertise in laboratory instrumentation, automation platforms, digital system integration, and GxP compliance, with the ability to collaborate across cross-functional teams in a fast-paced environment.

• Collaborate with internal and external business analysts, software engineers, and automation engineers to support the full product lifecycle management of Digital Quality Automation Systems and standalone analytical instrumentation.
• Support implementation, optimization, maintenance, troubleshooting, updates, and version upgrades for systems such as Hamilton Venus, Scitara DLX, Spectra Max M5, Hamilton Liquid Pipetting systems, and related laboratory technologies.
• Translate business, system, and data integration requirements into scalable digital laboratory solutions within GMP environments.
• Manage and support change control activities and regulatory documentation including SOPs, work instructions, knowledge base articles, and lifecycle documentation.
• Partner with digital stakeholders to validate and integrate systems into connected laboratory instrument pipelines, robotics platforms, automation initiatives, and AI-enabled solutions.
• Drive innovation and continuous improvement initiatives by identifying opportunities to optimize laboratory digital workflows and operational processes.
• Ensure GMP compliance is incorporated into the design, deployment, validation, and maintenance of all systems.
• Maintain inspection readiness through adherence to quality procedures, training requirements, and compliance standards.
• Participate in internal and external audits as the digital quality systems subject matter expert.
• Support multiple concurrent projects while collaborating within a cross-functional matrix organization.
• Travel between regional sites as required.
• Perform additional responsibilities as assigned.

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical field.
• 5–7+ years of experience designing, implementing, and managing analytical instrumentation and digital laboratory systems within a GMP-regulated biopharmaceutical environment.
• Hands-on experience with laboratory automation platforms such as Hamilton Venus or similar systems.
• Strong understanding of GxP, GAMP, and GMP compliance requirements.
• Experience with laboratory systems, instrument integration, data integrity regulations, and digital workflow optimization.
• Experience supporting cloud-hosted digital systems and understanding connectivity between on-premise systems and SaaS/Cloud environments.
• Experience with Linux Ubuntu SUDO commands is preferred.

• Strong analytical, troubleshooting, and problem-solving skills with a continuous improvement mindset.
• Ability to work independently and make effective technical decisions in a fast-paced environment.
• Strong knowledge of laboratory systems, quality management workflows, and digital quality processes.
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships.
• Ability to manage multiple priorities and projects simultaneously.
• Experience working within highly collaborative, matrixed organizations.
• Passion for innovation, automation, and digital transformation within the life sciences industry.