Principal Engineer, Drug Product, Global Engineering Technical Authority

Moderna • Norwood, MA

1d • $142,500 - $256,500 • Onsite

About The Position

The Principal Engineer, Drug Product will provide visionary leadership and technical expertise across global manufacturing operations, focusing on sterile drug product processes, including filling, packaging, and labeling equipment. This role will be responsible for building and leading a Technical Authority organization, ensuring the global standardization of facilities, process, equipment, and systems. The individual will drive excellence in both capital project execution and continuous improvement initiatives, while also providing critical support to ensure compliance with regulatory standards.
This position plays a key role in defining engineering best practices aligning with global manufacturing strategies and providing technical oversight across facilities worldwide. The ideal candidate will demonstrate expertise in filling, labeling, and packaging equipment in a regulated environment, leading cross-functional teams to achieve business goals.

Requirements

• Bachelor’s or Master’s degree in Engineering or a related technical field; advanced degree preferred.
• 15+ years of experience in engineering roles within the pharmaceutical industry, specifically with drug product manufacturing equipment such as filling, packaging, and labeling systems.
• Proven experience managing large-scale, global capital projects, and leading cross-functional technical teams.
• Deep understanding of regulatory and performance requirements for sterile manufacturing processes, including experience in FAT/SAT, commissioning, validation, and qualification.
• Demonstrated success in driving innovation, managing equipment vendors, and developing engineering standards across global sites.
• Strong leadership and communication skills, with the ability to influence senior stakeholders and lead global technical teams.
• Ability to manage multiple complex projects simultaneously while maintaining a focus on strategic objectives.
• Must be a U.S. person (citizen, permanent resident, asylee, or refugee) due to export control laws.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Lead the development of a Technical Authority organization to support manufacturing operations and provide expert guidance on engineering decisions for drug product processes globally.
• Act as the Global Subject Matter Expert (SME) in primary and secondary packaging, filling, labeling, closing equipment, and processes.
• Establish and maintain best practices and functional standards that enable global standardization of facilities, engineering processes, equipment, and systems.
• Lead the Front-End Engineering for capital projects, including scope determination, design review, manufacturability assessments, cost analysis, risk evaluation, and schedule planning for Drug Product projects.
• Oversee and participate in the complete project lifecycle, including conceptual design, engineering, procurement, construction, installation, start-up, commissioning, validation, and qualification of equipment.
• Ensure project documentation is accurate, comprehensive, and compliant with regulatory and internal standards, including URS, functional descriptions, and engineering drawings.
• Develop and own specifications for filling, labeling, and packaging equipment, leading the selection and assessment of equipment vendors.
• Collaborate with cross-functional teams to define user requirements, design specifications, and process parameters, providing input into risk assessments (FMEA) and operational strategies.
• Drive the development of Engineering Turnover Packages, ensuring accurate documentation, operating manuals, and GMP compliance for all process equipment.
• Ensure that all global manufacturing processes comply with regulatory requirements (e.g., GMP, FDA, ICH, EMA), including validation and qualification activities.
• Lead Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning of equipment at vendor locations and on-site.
• Support global qualification strategies, including vision systems for Automated Visual Inspection (AVI), and troubleshooting equipment failures while ensuring preventive maintenance and continuous improvement.
• Drive innovation by identifying new technologies for filling and closing equipment, primary and secondary packaging, and vision inspection systems.
• Lead testing and evaluation of new technologies to support the global technical roadmap, providing solutions for emerging business needs and continuous process improvements.
• Act as a technical influencer, providing guidance to senior leadership on business initiatives and strategic capital investments.
• Serve as a problem solver for complex engineering challenges, troubleshooting equipment, determining root causes of failures, and driving preventive maintenance initiatives.
• Support deviation investigations, change controls, and regulatory audits by providing expertise in process equipment and compliance.
• Lead the creation and optimization of machine recipes, and support re-qualification and inspections as needed across global sites.

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

What This Job Offers

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