Principal Engineer, DP Packaging Equipment - BioSpace : Job Details

Job Details The Role In this role, you will lead the Label and Secondary Packaging Engineering efforts for capital projects across Moderna's global operations, supporting both clinical and commercial supply chains. The engineer will also provide technical guidance to existing manufacturing facilities. Here's What You'll Do

• Lead the development of labeling and packaging equipment specifications.
• Manage Front End Planning (FEP) activities, working cross-functionally to define scope, design, manufacturability, cost, capital, risk, and schedules for capital projects.
• Drive vendor selection and assessment processes for packaging equipment.
• Provide input into user requirements, design specifications, process parameters, and FMEA assessments.
• Establish and maintain best practices and functional standards for packaging to promote global standardization of equipment, processes, and systems.
• Translate business needs into engineering solutions, incorporating an understanding of both commercial and clinical secondary packaging requirements.
• Act as the Subject Matter Expert (SME) for secondary packaging, driving alignment on procedures and standards within internal and cross-divisional teams.
• Execute and direct the design of processes and equipment, leveraging innovative engineering techniques and benchmarking both internally and externally.
• Identify and evaluate new technologies for secondary packaging equipment and printed materials, conducting testing as part of the technical roadmap.
• Provide technical support to Moderna's external supply manufacturing network, troubleshooting issues, recommending design improvements, and contributing to continuous improvement efforts.
• Lead and manage capital projects, ensuring adherence to project timelines and preventing delays.
• Participate in all phases of engineering projects, from conceptual design to commissioning, validation, and qualification.
• Troubleshoot equipment failures, contribute to preventative maintenance plans, assess change controls, and support continuous improvement initiatives.
• Review and guide the work of vendors and consultants while managing multiple complex assignments simultaneously.
• Develop and update Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
• Additional duties as may be assigned from time to time

Here's What You'll Need (Basic Qualifications)

• A Bachelor's or Master's degree preferably in Packaging, Mechanical or Automation Engineering. Other engineering degrees will be considered.
• Minimum of 12 years of relevant experience as a Packaging Engineer

Here's What You'll Bring to the Table (Preferred Qualifications)

• Minimum 5 years of experience in a GMP environment
• A technical and regulatory background in labeling and secondary packaging requirement in pharmaceutical/Biotech industry.
• Experience in large capital/expansion programs with direct design responsibility
• Experience with a Thermoforming, Heat Sealing, Plunger Insertion Side Load and Top Load Cartoning, Flexible Packaging Line Design, Vision Inspection Systems, Serialization and on-line barcode printing and verification and coding,
• Working knowledge of, Automatic Inspection and Clinical Packaging Operations would be preferred.
• Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required.
• Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.
• Familiarity with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.
• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
• Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected] . Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1 -