The Role
In this role, you 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 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.
Here’s What You’ll Do
- 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, and closing equipment, and processes.
- Establish and maintain best practices and functional standards that enable global standardization of engineering processes, equipment, and systems.
- Capital Project Leadership:
- Lead the Front End Planning (FEP) for capital projects, including scope determination, design review, manufacturability assessments, cost analysis, risk evaluation, and schedule planning.
- Oversee and participate in the complete project lifecycle, including conceptual design, 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, 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.
- Training and Development:
- Develop and maintain global training standards for technicians and engineering teams, ensuring best practices are followed across all facilities.
- Additional duties as may be assigned from time to time
Here’s What You’ll Need (Basic Qualifications)
- Bachelor’s or Master’s degree in Engineering or a related technical field; advanced degree preferred.
- At least 15 years of experience in engineering roles within the pharmaceutical industry, specifically with drug product manufacturing equipment such as filling, packaging, and labeling systems.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- 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.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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, 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.
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 modernatx.com/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. We’re 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
