Senior Engineer I, Process Engineering

BioSpace; Norwood (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family planning support

Paid time off

Retirement savings

Job summary

Moderna is seeking a process engineering SME to support Drug Substance technologies like IVT, chromatography, TFF, and LNP across its global manufacturing network. You will ensure designs are robust, compliant, and scalable for clinical and commercial production.

You will collaborate with R&D, MS&T, and Manufacturing, develop PFDs/P&IDs/URS/FRS, contribute to CIP, and drive continuous improvement while maintaining GxP/GMP compliance and training readiness.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field required; Master’s preferred.
• 7–10 years of process engineering/manufacturing science experience in biopharmaceuticals or sterile manufacturing.
• Hands-on experience with Drug Substance processes such as IVT, chromatography, TFF, and LNP systems.
• Experience supporting process design/equipment specs in regulated manufacturing;
• Experience with process simulation/modeling (mass/energy balances, scale-up, dynamic or steady-state).

Responsibilities

• Serve as SME for Drug Substance processes (IVT, Chromatography, TFF, LNP).
• Design, scale-up, and implement modular process skids in line with GxP and Moderna standards.
• Develop PFDs, P&IDs, URS, and FRS for Drug Substance manufacturing systems.
• Contribute to CIP system design and optimization for safety, efficiency, reliability.
• Collaborate with stakeholders and vendors on equipment design and automation.
• Support root cause investigations, deviations, and continuous improvement.
• Contribute to technical reviews and standardization under Technical Authority governance.
• Ensure compliance with GxP/GMP and Moderna quality systems.
• Maintain training, documentation, and audit readiness.
• Mentor junior engineers and drive continuous technical excellence.

Skills

Process engineering

Cross-functional collaboration

Problem-solving

Mentoring

Education

Bachelor’s degree in Chemical Engineering / Biochemical Engineering

Master’s degree preferred

Tools

IVT

Chromatography

TFF

LNP systems

PAT

Automation strategies

Job description

The Role

The candidate in this position will provide advanced technical expertise within the Global Engineering Technical Authority, supporting the design, implementation, and optimization of Drug Substance process technologies across Moderna’s 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 Role

The candidate in this position will provide advanced technical expertise within the Global Engineering Technical Authority, supporting the design, implementation, and optimization of Drug Substance process technologies across Moderna’s 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 Moderna’s engineering and quality standards.

Here’s What You’ll 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 Moderna’s 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 Moderna’s Technical Authority governance model.
• Ensure compliance with GxP/GMP regulations and Moderna’s 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.

Here’s What You’ll Need (Basic Qualifications)

• Education: Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related field required. Master’s degree preferred.
• Experience: Minimum of 7-10 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.

Here’s What You’ll 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).
• Certifications/Training: 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

• Competitive healthcare, 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 investments to help you plan for the future
• Location-specific perks and extras

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you at work, at home, and everywhere in between.

The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.

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.

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 person’s 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 law. Moderna 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.

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re 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 [e-mail].

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 applicant’s 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.