GxP Systems Engineer (Olive Branch)
Job DescriptionGxP Systems Engineer – Digital Quality Systems(Assigned to Pushpit )Location: Norwood & Marlborough, MADepartment: Digital Quality / GxP Digital SystemsLevel: 6Position OverviewModerna 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 ResponsibilitiesDigital Quality & System EngineeringDesign, 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:ImplementationSystem optimizationMaintenanceTroubleshootingValidation supportVersion upgradesWork with platforms and systems such as:Hamilton VenusScitara DLXHamilton Liquid Handling SystemsSpectraMax M5Connected laboratory instrumentationSystem Integration & Digital ConnectivityTranslate laboratory, business, and integration requirements into scalable digital lab solutions.Support instrument integration and data connectivity between:On-premise laboratory systemsCloud/SaaS digital platformsEnterprise data ecosystemsPartner with Digital and Automation teams to support:Connected instrument pipelinesRobotics and automation initiativesAI-enabled laboratory capabilitiesDigital workflow optimizationCompliance & ValidationEnsure all systems comply with:GxP regulationsGMP requirementsData integrity standardsGAMP guidelinesSupport and maintain validation and compliance documentation including:SOPsWork InstructionsChange ControlsKnowledge Base ArticlesLifecycle DocumentationMaintain inspection readiness and participate in internal/external audits as Digital Quality SME.Continuous Improvement & CollaborationDrive 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 QualificationsBachelor's Degree in:EngineeringComputer ScienceLife SciencesRelated Technical Discipline5–7+ years of experience supporting analytical instrumentation and laboratory digital systems in a GMP-regulated biopharmaceutical environment.Hands-on experience with:Laboratory automation systemsInstrument integrationLaboratory digital workflowsGxP-compliant systemsExperience with:GAMPGMPData Integrity regulationsChange control processesUnderstanding of cloud-hosted Digital systems and connectivity between on-premise and SaaS/Cloud platforms.Strong troubleshooting and systems integration experience.Preferred QualificationsDirect experience with:Hamilton VenusScitara DLXHamilton Liquid Pipetting SystemsSpectraMax M5Experience with Linux Ubuntu and SUDO commands.Familiarity with:Robotics integrationAI-enabled laboratory systemsConnected laboratory ecosystemsStrong understanding of:Laboratory Quality Management workflowsDigital Quality systemsInstrument data integrationDesired Skills & CompetenciesStrong 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.