System Engineer

Job Description – GxP Systems EngineerJob Function: Digital (GxP Digital Quality Systems)Location: Norwood & Marlborough, MA Position OverviewWe are seeking a GxP Systems Engineer for our client, a leading biotechnology organization, to support the design, implementation, and management of advanced automation and digital instrumentation systems within Quality Control GMP laboratories. This role will focus on enabling seamless integration between laboratory instruments, automation platforms, and enterprise digital ecosystems to drive operational excellence and regulatory compliance.The ideal candidate will combine strong technical expertise, hands-on problem-solving ability, and collaboration skills to support innovative laboratory technologies in a fast-paced biopharmaceutical environment.Key ResponsibilitiesCollaborate with internal stakeholders, external partners, business analysts, and automation/software engineers to manage the full lifecycle of Digital Quality Automation Systems and analytical instrumentation, including implementation, optimization, maintenance, upgrades, and ongoing support.Support systems such as Hamilton Venus, Scitara DLX, SpectraMax M5, Hamilton liquid handling platforms, and related laboratory technologies.Translate business, system, and data integration requirements into scalable digital laboratory solutions within a GMP-regulated environment.Develop, manage, and maintain GxP documentation including SOPs, work instructions, knowledge base articles, validation records, and change control documentation.Partner with digital and quality stakeholders to validate and integrate laboratory systems into connected digital platforms, robotics/automation initiatives, and future AI-enabled capabilities.Promote innovation by identifying opportunities to improve processes, optimize workflows, and implement emerging technologies.Apply operational excellence principles to enhance system reliability, performance, compliance, and user experience.Ensure GMP and GxP compliance requirements are embedded throughout the design, deployment, and maintenance lifecycle of all systems.Maintain inspection readiness through adherence to quality standards, procedures, and training requirements.Participate in internal and external audits as the digital quality subject matter expert for assigned systems.Provide on-site support and travel between regional sites as needed.Perform additional responsibilities as assigned.Required QualificationsBachelor’s degree in Science, Engineering, Computer Science, or a related discipline, or equivalent experience.5–7+ years of experience designing, implementing, and supporting analytical instrumentation and laboratory systems within a biopharmaceutical GMP environment.Hands-on experience with laboratory automation platforms, preferably Hamilton Venus.Understanding of GAMP and GxP compliance requirements and validation practices.Experience with laboratory systems, instrument integration, data integrity standards, and digital workflow optimization.Familiarity with cloud-hosted digital platforms and connectivity between on-premises systems and SaaS/cloud environments.Experience with Linux Ubuntu and SUDO commands is a plus.Preferred QualificationsStrong analytical, troubleshooting, and problem-solving capabilities with an innovative mindset.Ability to work independently and make timely, effective decisions in a fast-paced environment.Solid understanding of laboratory operations, quality systems, and workflow management processes.Excellent interpersonal and collaboration skills with the ability to build effective cross-functional relationships.Proven ability to manage multiple concurrent projects and priorities.Experience working within dynamic, matrixed organizations.Passion for contributing to an innovative, high-growth, and collaborative environment focused on continuous improvement and digital transformation