Principal Engineer, Drug Product, Global Engineering Technical Authority
Moderna
Summary
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.
Job description
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, 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, 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 optimization of machine recipes, and support re-qualification and inspections as needed across global sites.
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.
Benefits
- Competitive healthcare
- Voluntary benefit programs
- Fitness support
- Mindfulness support
- Mental health support
- Fertility support
- Adoption support
- Surrogacy support
- Generous paid time off
- Vacation
- Volunteer days
- Sabbatical
- Global recharge days
- Year-end shutdown
- Savings and investments
- Location-specific perks
Company overview
Moderna, Inc. is a pioneering American biotechnology and pharmaceutical company headquartered in Cambridge, Massachusetts, that has revolutionized the field of medicine through its groundbreaking messenger RNA (mRNA) technology. Founded in 2010, the company has established itself as a global leader in RNA therapeutics, primarily focusing on mRNA vaccines and treatments. Moderna's innovative platform uses mRNA to provide cellular instructions for producing proteins that trigger immune responses, creating a new category of medicines with significant potential to improve patient outcomes across various therapeutic areas. The company gained worldwide recognition during the COVID-19 pandemic for developing one of the earliest and most effective mRNA vaccines, which demonstrated the transformative potential of its technology platform. Beyond infectious diseases, Moderna is advancing a diverse pipeline of 44 treatment and vaccine candidates across infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune conditions. With approximately 5,800 employees and a strong commitment to scientific innovation, Moderna continues to expand its manufacturing capabilities and research initiatives to deliver the greatest possible impact through mRNA medicines.