Principal, Process Engineering, Global Engineering Technical Authority
Moderna · Norwood, Massachusetts, United States
The Role:
The Principal Engineer, Process Engineering, Global Engineering Technical Authority will be based in Norwood, MA.
The Principal Engineer, Process Engineering will serve as a global technical leader and Subject Matter Expert (SME) within Moderna's Global Engineering Technical Authority (GETA), providing technical direction, engineering oversight, and lifecycle support for GMP drug substance manufacturing process equipment across Moderna's global manufacturing network.
This individual will collaborate closely with Facilities, Manufacturing, Process Development, and other cross-functional stakeholders to design, evaluate, and implement innovative process technologies and support state-of-the-art manufacturing capabilities.
The ideal candidate will bring strong technical expertise in biopharmaceutical process equipment, particularly pump technologies, process sensors, and instrumentation, along with a demonstrated ability to identify, evaluate, and implement emerging manufacturing technologies. This position will play an important role in advancing manufacturing capabilities, improving process robustness, and enabling the integration of new technologies into GMP manufacturing environments.
The successful candidate will demonstrate deep technical expertise, independent engineering judgment, strong problem-solving capabilities, and a proven ability to influence cross-functional stakeholders, mentor technical talent, and lead complex engineering initiatives.
Here’s What You’ll Do:
- Serve as a global technical leader and Subject Matter Expert within the Global Engineering Technical Authority, providing technical direction, engineering oversight, and lifecycle support for GMP drug substance manufacturing process equipment across Moderna’s global manufacturing network.
- Lead cross-functional teams of subject matter experts responsible for supporting drug substance manufacturing and developing engineering projects. Provide technical guidance, coaching, and work-prioritization support across engineering teams while operating as a senior individual contributor.
- Provide technical leadership and oversight throughout the full capital project lifecycle, including conceptual design, front-end engineering, detailed design, equipment specification and selection, procurement, construction, installation, startup, commissioning, and qualification.
- Ensure capital projects and equipment solutions remain aligned with global engineering standards, operational requirements, user requirements, quality expectations, and applicable regulatory requirements.
- Serve as the global technical SME and Engineering Owner for drug substance process equipment, including ultrafiltration systems, chromatography systems, single-use mixers, Clean-in-Place systems, temperature control units, reaction vessels, and associated equipment.
- Act as Engineering Owner for assigned process equipment, providing technical stewardship from initial design and implementation through operation, optimization, and lifecycle improvement.
- Establish technical direction for the design, optimization, and lifecycle management of drug substance manufacturing unit operations, driving consistent engineering practices, equipment reliability, process robustness, and continuous improvement across Moderna’s global manufacturing network.
- Bring deep technical expertise in pump technologies and process instrumentation, including the evaluation, selection, design integration, troubleshooting, and optimization of pumps, sensors, instrumentation, and associated process-control components used in biopharmaceutical manufacturing.
- Drive the identification, technical evaluation, and strategic implementation of innovative manufacturing technologies that improve process efficiency, equipment reliability, scalability, and operational performance.
- Assess emerging manufacturing technologies through technical feasibility studies, engineering evaluations, and collaboration with equipment and technology suppliers. Develop implementation recommendations based on process requirements, GMP suitability, technical risks, scalability, and operational benefits.
- Partner closely with Research, Process Development, and Manufacturing teams during early stages of process development to evaluate new manufacturing technologies and support the selection of scalable, robust, and GMP-compatible solutions.
- Lead complex engineering evaluations, technical studies, troubleshooting activities, and equipment performance assessments, translating findings into clear technical recommendations and guiding implementation of solutions that strengthen manufacturing capability, reliability, and process performance.
- Provide technical oversight and approval of engineering design documentation, equipment specifications, commissioning strategies, and qualification deliverables within delegated authority.
- Design and optimize single-use consumables, ensuring functional requirements are clearly defined and that supplier selection is aligned with sourcing strategy.
- Collaborate with Facilities, Manufacturing, Process Development, Research, and other cross-functional stakeholders to design, evaluate, and implement innovative process technologies and support state-of-the-art manufacturing capabilities.
- Work directly with internal stakeholders and external equipment and technology suppliers to assess equipment capabilities, resolve complex technical challenges, and identify opportunities for manufacturing technology advancement.
- Use strong independent engineering judgment and structured problem-solving to influence technical decisions across functions, mentor technical talent, and lead complex engineering initiatives without direct people-management responsibility.
- Help create an environment in which new technologies can be responsibly integrated into GMP manufacturing, including opportunities to explore how Generative AI and other digital capabilities can support engineering knowledge management, technical assessments, equipment troubleshooting, supplier evaluation, and faster evidence-based decision-making.
The key Moderna Mindsets you’ll need to succeed in the role:
- “We act with dynamic range, driving strategy and execution at the same time at every step.”
- “We question convention because proven models don’t always fuel the future.”
Here’s What You’ll Need (Basic Qualifications)
Education:
- Bachelor's or Master’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
Experience & Requirements:
- Minimum of 10 years of relevant experience in process engineering or biopharmaceutical manufacturing engineering.
- Experience in a GxP biopharmaceutical operations environment preferred.
- Deep technical expertise in the design, selection, integration, and lifecycle management of bioprocess equipment, including ultrafiltration, chromatography, single-use mixers, buffer preparation vessels, temperature control units, fermenters, reaction vessels, and associated process systems.
- Proven track record of leading the technical evaluation, selection, and implementation of innovative manufacturing technologies, with consideration of process performance, technical feasibility, scalability, and GMP compatibility.
- Demonstrated expertise in pump technologies and process sensors used in biopharmaceutical manufacturing, including equipment selection, performance evaluation, troubleshooting, and integration into manufacturing processes.
- Strong understanding of pump operating principles, process measurement technologies, and their applications in maintaining reliable and consistent manufacturing operations.
- Demonstrated expertise in leading the resolution of complex technical challenges, applying independent engineering judgment, evaluating alternative engineering solutions, and translating technical assessments into practical recommendations and implementation plan