Principal, Process Engineering, Global Engineering Technical Authority

Moderna • Norwood, MA

3d • $142,500 - $256,500 • Hybrid

About The Position

The Principal Engineer, Process Engineering, Global Engineering Technical Authority is based in Norwood, Massachusetts, and serves as a global technical leader and subject matter expert within Moderna’s Global Engineering Technical Authority (GETA). The role provides technical direction, engineering oversight, and lifecycle support for GMP drug substance manufacturing process equipment across Moderna’s global manufacturing network.

The position partners with Facilities, Manufacturing, Process Development, Research, and other stakeholders to design, evaluate, and implement process technologies and support advanced manufacturing capabilities. It serves as Engineering Owner for assigned drug substance equipment, providing stewardship from design and implementation through operation, optimization, and lifecycle improvement. Equipment includes ultrafiltration and chromatography systems, single-use mixers, Clean-in-Place systems, temperature control units, reaction vessels, and associated process systems. Particular expertise in pump technologies, process sensors, and instrumentation is central to the role.

The Principal Engineer leads technical evaluations, complex engineering studies, troubleshooting, and equipment performance assessments. The role guides capital projects through conceptual design, engineering, equipment selection and procurement, construction, installation, startup, commissioning, and qualification, while ensuring alignment with engineering standards, operational and user requirements, quality expectations, and applicable regulations. It also evaluates emerging technologies and supports their responsible integration into GMP manufacturing, including potential use of Generative AI and other digital capabilities for engineering knowledge management and evidence-based decisions.

Operating as a senior individual contributor without direct people-management responsibility, the role leads and influences cross-functional technical teams, coaches and mentors technical talent, and delivers complex initiatives with independent engineering judgment. The position follows Moderna’s 70/30 in-office work model in Norwood and may require travel up to 25%.

Requirements

• Bachelor’s or master’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• At least 10 years of relevant experience in process engineering or biopharmaceutical manufacturing engineering.
• Deep expertise in 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.
• Demonstrated expertise in pump technologies and process sensors used in biopharmaceutical manufacturing, including selection, performance evaluation, troubleshooting, and integration.
• Strong understanding of pump operating principles and process measurement technologies and their applications in reliable, consistent manufacturing operations.
• Experience with pharmaceutical processing equipment and unit operations.
• Experience designing and optimizing single-use consumables.
• Comprehensive understanding of regulatory requirements and their application in a cGMP environment.
• Experience with commissioning and qualification of facilities, utilities, systems, and equipment.
• Proven experience providing technical leadership on complex capital projects from conceptual design through commissioning and qualification.
• Demonstrated ability to lead resolution of complex technical challenges, exercise independent engineering judgment, evaluate alternative engineering solutions, and translate assessments into practical recommendations and implementation plans.
• Exceptional technical analysis, engineering judgment, problem-solving, and technical communication capabilities.
• Ability to influence and lead cross-functional technical teams, take ownership of assignments, and deliver results on multiple complex projects with minimal supervision.
• Ability to represent Moderna’s interests, objectives, and policies professionally and responsibly.
• Excellent written and verbal English communication skills.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Ability to travel up to 25%.

Nice To Haves

• Experience in a GxP biopharmaceutical operations environment.
• Familiarity with statistical analysis techniques.

Responsibilities

• Serve as a global technical leader and subject matter expert within GETA, providing technical direction, oversight, and lifecycle support for GMP drug substance manufacturing process equipment.
• Lead cross-functional subject matter expert teams supporting drug substance manufacturing and engineering projects; provide technical guidance, coaching, and work-prioritization support.
• Provide technical leadership and oversight across the capital project lifecycle, from conceptual design and front-end engineering through detailed design, procurement, construction, installation, startup, commissioning, and qualification.
• Ensure projects and equipment solutions align with global engineering standards, operational and user requirements, quality expectations, and applicable regulatory requirements.
• Serve as 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.
• Provide technical stewardship for assigned equipment from initial design and implementation through operation, optimization, and lifecycle improvement.
• Establish technical direction for design, optimization, and lifecycle management of drug substance manufacturing unit operations to improve engineering consistency, equipment reliability, process robustness, and continuous improvement.
• Evaluate, select, integrate, troubleshoot, and optimize pumps, sensors, instrumentation, and associated process-control components used in biopharmaceutical manufacturing.
• Identify, technically evaluate, and recommend strategic implementation of manufacturing technologies to improve process efficiency, reliability, scalability, and operational performance.
• Assess emerging technologies through feasibility studies, engineering evaluations, and supplier collaboration; develop recommendations considering process requirements, GMP suitability, technical risks, scalability, and operational benefits.
• Partner with Research, Process Development, and Manufacturing during early process development to evaluate technologies and select scalable, robust, GMP-compatible solutions.
• Lead complex engineering evaluations, technical studies, troubleshooting, and equipment performance assessments; translate findings into recommendations and guide implementation.
• Provide technical oversight and approval, within delegated authority, for engineering design documentation, equipment specifications, commissioning strategies, and qualification deliverables.
• Design and optimize single-use consumables, define functional requirements, and align supplier selection with sourcing strategy.
• Collaborate with internal stakeholders and external equipment and technology suppliers to assess equipment capabilities, resolve technical challenges, and identify technology advancement opportunities.
• Use independent engineering judgment and structured problem-solving to influence technical decisions, mentor technical talent, and lead complex initiatives without direct people-management responsibility.
• Support responsible integration of new technologies into GMP manufacturing, including exploring Generative AI and digital capabilities for knowledge management, technical assessments, troubleshooting, supplier evaluation, and evidence-based decision-making.
• Travel up to 25%.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Well-being resources, including fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs.
• Location-specific perks and extras.
• Potential eligibility for an annual discretionary bonus, other incentive compensation, or equity award, subject to plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal