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Manufacturing / Automation Engineering, Senior Manage

$145.9k - $234.2k

Moderna

Advanced Manufacturing Systems Leader
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.
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

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

Ensure adherence to 21 CFR Part 11, Annex 11, and data integrity requirements
Lead and support CSV (IQ/OQ/PQ) activities and risk assessments
Identify and implement process improvements to enhance reliability, scalability, and efficiency
Champion continuous improvement initiatives across automation systems

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
Bachelor's degree or master's Degree in engineering plus related field or relevant experience; 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., 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 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 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. For this role, we are currently unable to offer immigration sponsorship. Creative, analytical, and strong problem-solving skills

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 effectively in a cross-functional, fast-paced project environment
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
Savings and investment opportunities to help you plan for the future
An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.

Vacancy posted 1 day ago
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