Principal Engineer, Drug Product

## Principal Engineer, Drug Product Apply:
Norwood, Massachusetts:
Drug Manufacturing:
Full time:
Posted Today:
R19992
*
* The Role:

** The Principal Engineer, Drug Product will provide technical leadership and expertise across Moderna’s global manufacturing network, including operations in the United States, Australia, Canada, and the United Kingdom. The role will focus on sterile drug product processes and associated manufacturing technologies, including filling, inspection, packaging, and labeling equipment. This individual will establish global engineering standards in the Technical Authority organization, and drive consistency across facilities, processes, equipment, and systems.

This position plays a key role in defining engineering best practices aligned with Moderna’s global manufacturing strategy and providing technical oversight across the manufacturing network. The Principal Engineer will support capital projects, continuous improvement initiatives, and resolution of complex technical challenges while ensuring alignment with regulatory requirements and Moderna standards. The ideal candidate will demonstrate deep expertise in filling, inspection, labeling, and packaging equipment within a regulated environment and the ability to lead and influence cross-functional teams across global locations.

*
* Key Responsibilities:

**** Global Technical Leadership:*
* * 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, inspection, 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.  
** Capital Project Leadership:*
* * 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.  
** Equipment Specification and Vendor Management:*
* * Develop and own specifications for filling, inspection, 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.  
** Regulatory Compliance and Testing:*
* * 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.  
** Innovation 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.  
** Operational Excellence and Problem-Solving:*
* * 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…