Senior Engineer II, Automation, INT
Norwood, MN - USA
Job Summary
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 Modernas Marlborough MA office.
Heres What Youll Do
Lead Automation Strategy & Architecture
- Define and implement automation architectures aligned with ISA-95 (Levels 03) 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
Heres What Youll Need (Basic Qualifications)
- Bachelors degree or masters 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 Modernas 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.
Heres What Youll 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. Thats why our US benefits and global well-being resources are designed to support youat 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 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
About Moderna
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.S.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.
Our Working Model
As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
Moderna is a smoke-free alcohol-free and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Accommodations
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .
Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-SB2-
Required Experience:
Senior IC
About Company
Learn how we’re changing the world of medicine. Discover career opportunities, our product pipeline, and browse media resources. Meet Moderna.