Senior Engineer II, Automation, INT

ModernaTX • Norwood, MA

7d • Onsite

About The Position

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.

Requirements

• 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.
• Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
• Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

Benefits

• 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, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Senior