Senior Engineer II, Automation, INT

The Role Moderna 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 & Architecture Define and implement automation architectures aligned with ISA-95 (Levels 0–3) and ISA-88 standards Design scalable, modular systems to support manufacturing of individualized therapy   Own Project Delivery & Lifecycle Management Lead CAPEX projects from concept through commissioning and transition into OPEX Provide ongoing lifecycle support for automation systems across Moderna facilities    Drive Cross-Functional Collaboration Partner with MSAT, Manufacturing, Process Engineering, Quality, IT, Facilities, and other stakeholders to define requirements and deliver solutions   Development of Novel and New Technologies Lead the automation design for novel and new technologies Oversee deployment and support of DeltaV, PLCs, SCADA, AVEVA PI, and robotics systems Support Factory Acceptance Testing (FAT), commissioning, and validation activities   Digital Integration & Data Strategy Develop and maintain APIs and integrations across platforms (data lakes, WMS, ERP) Enable data-driven manufacturing through connectivity and analytics-ready systems Promote an AI/ML-forward mindset in system design and data utilization    Compliance & Validation Ensure adherence to 21 CFR Part 11, Annex 11, and data integrity requirements Lead and support CSV (IQ/OQ/PQ) activities and risk assessments Own change control processes and maintain documentation per GDP standards    Operational Excellence Identify and implement process improvements to enhance reliability, scalability, and efficiency Champion continuous improvement initiatives across automation systems Provide On-call and floor support    Leadership & Mentorship Provide 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 systems Here’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 DCS Knowledge of advanced data analytics with multi-variate software such as SIMCA Familiarity with Robotics, PLCs, and SCADA systems Experience developing RESTful APIs and system integrations Experience 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 documentation Experience 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 skills Ability to work independently and make sound and timely decisions to achieve expected results Ability 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 environment Ability to work hard to effect change in a dynamic, high standards environment while maintaining a positive approach with management and peers Strong interpersonal skills with the ability to build successful professional working relationships  Ability to work effectively in a cross-functional, fast-paced project environment A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative Pay & Benefits At 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 needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, includin