Senior Engineer I, Process Engineering
Norwood, MN - USA
Job Summary
The Role:
The candidate in this role will provide advanced technical expertise within the Global Engineering Technical Authority supporting the design implementation and optimization of Drug Substance process technologies across Modernas global manufacturing network. This role focuses on ensuring process and equipment designs are robust compliant and scalable for commercial and clinical production of mRNA and lipid nanoparticle (LNP) drug substance platforms.
The individual will act as a process engineering subject matter expert (SME) collaborating with cross-functional teams in R&D MS&T and Manufacturing to apply standardized design practices and deliver innovative solutions aligned with Modernas engineering and quality standards.
Heres What Youll Do
Serve as a technical SME for key Drug Substance processes including In Vitro Transcription (IVT) Chromatography Tangential Flow Filtration (TFF) Lipid Mixing (LMX) and Lipid Nanoparticle (LNP) formulation.
Support the design scale-up and implementation of modular and small-scale process skids in alignment with GxP requirements and Modernas global standards.
Participate in the development of process flow diagrams (PFDs) P&IDs User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) for Drug Substance of manufacturing systems.
Contribute to Clean-In-Place (CIP) system design and optimization focusing on process safety efficiency and reliability.
Collaborate with internal stakeholders and vendors to ensure equipment design specifications and automation strategies meet performance quality and safety objectives.
Support root cause investigations deviation analysis and continuous improvement projects to enhance process performance and reliability.
Contribute to technical reviews design evaluations and standardization initiatives under Modernas Technical Authority governance model.
Ensure compliance with GxP/GMP regulations and Modernas quality and documentation systems.
Maintain required training documentation and audit readiness.
Mentor junior engineers and contribute to the continuous improvement of technical and operational excellence within Global Engineering.
Heres What Youll Need (Basic Qualifications)
Bachelors degree in Chemical Engineering Biochemical Engineering or a related field required. Masters degree preferred.
Minimum of 710 years of experience in process engineering or manufacturing science roles in a biopharmaceutical biotechnology or sterile manufacturing environment.
Hands-on experience with Drug Substance processes such as IVT chromatography TFF and LNP systems.
Proven ability to support process design and equipment specification in a regulated manufacturing setting.
Demonstrated experience in process simulation and modeling (e.g. mass and energy balances scale-up modeling dynamic or steady-state process simulation) to support process design capacity analysis and technology transfer.
This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.
Heres What Youll Bring to the Table (Preferred Qualifications)
Familiarity with bioprocess skid design automation and process analytical technologies (PAT).
Experience supporting or leading cross-functional technical projects.
Exposure to personalized medicine or individualized manufacturing processes (e.g. INT).
GxP/GMP compliance training.
Strong understanding of FDA EMA and ICH regulations.
Strong communication and collaboration skills across functional teams and organizational levels.
Demonstrated ability to manage multiple technical priorities within a fast-paced matrixed environment.
Proven problem-solving and analytical skills to identify and resolve complex technical issues.
Commitment to data integrity safety and quality excellence in all work activities.
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-NB1-
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.