Principal Engineer, Drug Product

Moderna Therapeutics; South (KY); In loco; USD 143.000 - 257.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare

Well-being program

Family planning benefits

Paid time off

Descrizione del lavoro

Moderna seeks a Principal Engineer, Drug Product to provide global technical leadership for sterile drug product processes across the U.S. and international sites.

The role focuses on filling, inspection, labeling, and packaging equipment, establishing global standards and supporting capital projects from concept to validation. The ideal candidate will have 15+ years in pharmaceutical engineering, deep regulatory knowledge for GMP environments, and proven ability to lead cross-functional teams

Competenze

• Bachelor’s or Master’s degree in Engineering or related field.
• 15+ years of experience in engineering roles within the pharmaceutical industry.
• Deep understanding of regulatory and performance requirements for sterile manufacturing processes.

Mansioni

• Provide global technical leadership for drug product processes across the manufacturing network.
• Lead Front-End Engineering for capital projects, including scope, design, cost, risk, and schedule.
• Develop and own equipment specifications for filling, inspection, labeling, and packaging equipment; manage vendors.
• Ensure regulatory compliance and lead FAT/SAT, commissioning, and validation activities across sites.

Conoscenze

Technical leadership

Cross-functional teams

Regulatory compliance

GMP knowledge

Formazione

Bachelor’s or Master’s degree in Engineering

Descrizione del lavoro

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 optimization of machine recipes, and support re-qualification and inspections as needed across global sites.

Required Background:

Education:

Education: Bachelor’s or Master’s degree in Engineering or a related technical field; advanced degree preferred.

Experience & Requirements:

Experience & Requirements: 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.

Our Working Model

As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands‑on partnership needed to deliver our mission. 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.

Pay & Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

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. 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 [e-mail].

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.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.