Senior Engineer II, Automation, INT

The RoleModerna is seeking an Individual to lead the design, implementation, and lifecycle management of advanced manufacturing systems supporting the production of Individualized Neoantigen Therapies (INT).This role sits at the intersection of process automation, and next-generation therapeutics, requiring both strategic thinking and hands-on technical execution. You will play a key role in scaling personalized medicine through robust, compliant, and highly integrated automation platforms.As a senior member of the Process Automation team, you will drive innovation across systems architecture, data integration, and smart manufacturing initiatives, driving towards lights out manufacturing while collaborating in a highly cross-functional environment.This position is based in Moderna’s Marlborough, MA office.Here’s What You’ll Do   Lead Automation Strategy & ArchitectureDefine and implement automation architectures aligned with ISA-95 (Levels 0–3) and ISA-88 standardsDesign scalable, modular systems to support manufacturing of individualized therapy  Own Project Delivery & Lifecycle ManagementLead CAPEX projects from concept through commissioning and transition into OPEXProvide ongoing lifecycle support for automation systems across Moderna facilities   Drive Cross-Functional CollaborationPartner with MSAT, Manufacturing, Process Engineering, Quality, IT, Facilities, and other stakeholders to define requirements and deliver solutions  Development of Novel and New TechnologiesLead the automation design for novel and new technologiesOversee deployment and support of DeltaV, PLCs, SCADA, AVEVA PI, and robotics systemsSupport Factory Acceptance Testing (FAT), commissioning, and validation activities  Digital Integration & Data StrategyDevelop and maintain APIs and integrations across platforms (data lakes, WMS, ERP)Enable data-driven manufacturing through connectivity and analytics-ready systemsPromote an AI/ML-forward mindset in system design and data utilization   Compliance & ValidationEnsure adherence to 21 CFR Part 11, Annex 11, and data integrity requirementsLead and support CSV (IQ/OQ/PQ) activities and risk assessmentsOwn change control processes and maintain documentation per GDP standards   Operational ExcellenceIdentify and implement process improvements to enhance reliability, scalability, and efficiencyChampion continuous improvement initiatives across automation systems   Leadership & MentorshipProvide technical leadership and mentorship to cross- functional teams included but not limited to automation, process engineers and manufacturing.Support initiatives involving robotics and fleet management systemsHere’s What You’ll Need (Basic Qualifications)Bachelor’s degree or master’s Degree in engineering plus related field or relevant experience; a combination of education and experience may be considered.9 - 12 years of solid experience working in combination of manufacturing and lab systems in Pharmaceutical/Biotechnology.Experience with translating requirements against ISA-95 & ISA-88 structure.Strong automation background in DeltaV Control System including both continuous and batch processes. Well verse in S88 batch recipe creation, implementation, and troubleshooting.Well verse working with industrial protocols including HART, Ethernet I/P, OPC and classic IO.Hands-on experience with middleware tools (e.g., Kepware, OPC servers)Knowledge integrating in-line PAT systems with DCSKnowledge of advanced data analytics with multi-variate software such as SIMCAFamiliarity with Robotics, PLCs, and SCADA systemsExperience developing RESTful APIs and system integrationsExperience in tech transfer processes between MSAT, Process Development, Technical Development, Process Engineering and Manufacturing.Strong background in CSV and regulatory compliance (21 CFR Part 11, Annex 11)Experience authoring, reviewing and approving FRS, URS, CDS documentationExperience with IQ/OQ/PQ validation process for digital manufacturing/lab systems and with computerized system validation activities according to 21 CFR Part 11, Annex 11 and other regulatory requirements.This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.Here’s What You’ll Bring to the Table (Preferred Qualifications)Creative, analytical, and strong problem-solving skillsAbility to work independently and make sound and timely decisions to achieve expected resultsAbility to react under pressure to any given situation that may arise, in a professional manner and with positive results, in support of a multi-location environmentAbility to work hard to effect change in a dynamic, high standards environment while maintaining a positive approach with management and peersStrong interpersonal skills with the ability to build successful professional working relationships Ability to work effectively in a cross-functional, fast-paced project environmentA desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and CollaborativePay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings