GxP Systems Engineer
Job Description GxP Systems Engineer – Digital Quality Systems(Assigned to Pushpit ) Location: Norwood & Marlborough, MA Department: Digital Quality / GxP Digital Systems Level: 6 Position Overview Moderna is seeking a highly motivated and technically skilled 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. This role will focus on supporting first-in-kind automation platforms, analytical instrumentation, and connected digital laboratory systems that enable Quality Control operations and enterprise-wide digital integration initiatives. The ideal candidate will combine strong technical expertise with a passion for innovation, operational excellence, compliance, and continuous improvement. The successful candidate will work cross-functionally with Digital, Quality, Automation, Validation, and Laboratory teams to ensure scalable, compliant, and reliable digital laboratory solutions. Key Responsibilities Digital Quality & System Engineering Design, implement, configure, maintain, and optimize Digital Quality automation systems and analytical instrumentation within GMP laboratory environments. Support the full lifecycle management of Digital Quality systems including: Implementation System optimization Maintenance Troubleshooting Validation support Version upgrades Work with platforms and systems such as: Hamilton Venus Scitara DLX Hamilton Liquid Handling Systems SpectraMax M5 Connected laboratory instrumentation System Integration & Digital Connectivity Translate laboratory, business, and integration requirements into scalable digital lab solutions. Support instrument integration and data connectivity between: On-premise laboratory systems Cloud/SaaS digital platforms Enterprise data ecosystems Partner with Digital and Automation teams to support: Connected instrument pipelines Robotics and automation initiatives AI-enabled laboratory capabilities Digital workflow optimization Compliance & Validation Ensure all systems comply with: GxP regulations GMP requirements Data integrity standards GAMP guidelines Support and maintain validation and compliance documentation including: SOPs Work Instructions Change Controls Knowledge Base Articles Lifecycle Documentation Maintain inspection readiness and participate in internal/external audits as Digital Quality SME. Continuous Improvement & Collaboration Drive operational excellence initiatives and identify opportunities to improve laboratory digital workflows and system performance. Foster innovation by leveraging emerging technologies and creative solutions. Collaborate effectively within cross-functional and matrixed teams across Digital, Quality, Manufacturing, Validation, and Laboratory Operations. Provide technical guidance and troubleshooting support to stakeholders and end users. Required Qualifications Bachelor’s Degree in: Engineering Computer Science Life Sciences Related Technical Discipline 5–7+ years of experience supporting analytical instrumentation and laboratory digital systems in a GMP-regulated biopharmaceutical environment. Hands-on experience with: Laboratory automation systems Instrument integration Laboratory digital workflows GxP-compliant systems Experience with: GAMP GMP Data Integrity regulations Change control processes Understanding of cloud-hosted Digital systems and connectivity between on-premise and SaaS/Cloud platforms. Strong troubleshooting and systems integration experience. Preferred Qualifications Direct experience with: Hamilton Venus Scitara DLX Hamilton Liquid Pipetting Systems SpectraMax M5 Experience with Linux Ubuntu and SUDO commands. Familiarity with: Robotics integration AI-enabled laboratory systems Connected laboratory ecosystems Strong understanding of: Laboratory Quality Management workflows Digital Quality systems Instrument data integration Desired Skills & Competencies Strong analytical and problem-solving abilities. Innovative mindset with passion for continuous improvement. Excellent communication and interpersonal skills. Ability to work independently and manage multiple concurrent projects. Strong collaboration skills within dynamic cross-functional teams. Ability to thrive in a fast-paced, evolving environment. Strong organizational and documentation skills. Customer-focused and quality-driven mindset.