Principal Engineer, Drug Product, Global Engineering

Job Details The Role: The Principal Engineer, Drug Product, will lead the design development, fabrication, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint for both Clinical and Commercial supply operations. The Principal Engineer will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle, leading projects in the Drug Product Engineering discipline and Aseptic Operations. This role involves cross-functional collaboration with R&D, Quality, Regulatory, and Manufacturing teams to ensure that drug products meet quality, safety, and efficacy standards. The Principal Engineer will also mentor junior engineers and contribute to strategic initiatives within the department. This role is based in Norwood, MA and reports to the Director of Global Engineering. Travel to support global manufacturing expansion could be up to 30% at critical project phases. Heres What Youll Do: Lead the design and development of aseptic manufacturing processes for Drug Product facilities. Lead Front End Planning (FEP) activities for the fill finish equipment scope on capital projects and programs. Lead equipment vendor selection and assessments. Develop user requirements, design specifications, process parameters, and FMEA assessments. Develop and maintain contamination control strategies to prevent microbial contamination. Ensure all aseptic operations adhere to Good Manufacturing Practices (GMP) and other relevant guidelines. Lead strategies for aseptic process commissioning, qualification and support Media Fills and process validation, support protocols development in compliance with regulatory requirements (e.g., FDA, EMA). Prepare and review technical documentation, including validation reports, standard operating procedures (SOPs), and regulatory submissions. Serve as a Subject Matter Expert and work closely with Manufacturing and other functional groups to implement and scale up aseptic processes. Provide technical leadership and guidance to junior engineers and others in equipment design, problem-solving efforts and troubleshoot aseptic process issues. Identify new technologies in aseptic processing and sterile manufacturing technologies. Drive results by owning deliverables and assuring on-time milestones completion in capital projects. Mentor and train team members on best practices in aseptic operations. Heres What Youll Bring to the Table: Ph.D. in Chemical Engineering, Mechanical, or a related field with 8+ years of relevant experience, or M.S. with 10+ years of relevant experience, or B.S. with 12+ years of relevant experience. Extensive experience in aseptic processing and sterile manufacturing. Proven track record of successful commissioning, qualification, validation, and commercialization of aseptic processes. Strong knowledge of GMP, ICH guidelines, and regulatory requirements for aseptic operations. Experience with various aseptic techniques and equipment (e.g., isolators, cleanrooms, sterilization methods). Excellent problem-solving and analytical skills. Strong project management and organizational abilities. Effective communication and interpersonal skills. Ability to work collaboratively in a cross-functional team environment. Proficiency in using aseptic process development and validation tools. Experience in large capital/expansion programs with direct design responsibility. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Must be able use technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions for complex problems. Proficient with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from supervisor. Ability to represent Modernas mindsets, objectives, and policies in a professional and responsible manner. Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: Highly competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including: Vacation, sick time and holidays Volunteer time to participate within your community Discretionary year-end shutdown Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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. 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. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit /careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free and drug-free work environment. 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 proud to be an equal opportunity workplace and is an affirmative action employer. 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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 . (EEO/AAP Employer) -

Created: 2024-10-19