Engineer II, Process Engineering

The Role:

The Engineer II will play a pivotal part in enhancing and leading our cutting-edge manufacturing processes and will serve as either a technical liaison for capital projects or for GMP manufacturing process equipment at Moderna's manufacturing facility in Norwood, MA. This role will focus on reducing manufacturing events, minimizing user interventions, and enhancing product quality and safety standards. The role involves direct engineering support, troubleshooting, and continuous improvement initiatives, ensuring operability and reliability of the equipment. The Engineer II will collaborate closely with MS&T, Facilities, Validation, and equipment End Users to ensure projects are executed efficiently and effectively, meeting objectives and timelines. Their contribution will be crucial in optimizing production capabilities and ensuring the seamless integration of new technologies and methods in manufacturing operations. The ideal candidate will thrive in a fast-paced, dynamic, and innovative environment.

Here's What You'll Be Doing:

• Provide direct engineering support and subject matter expertise for process equipment at Norwood, MA, including Ultrafiltration, Chromatography, Mix Skid, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, CIP, Aseptic Filling Lines, Isolators, Visual Inspection Machines, Packaging Lines, Formulation Equipment, Analytical Equipment, Component Prep Equipment, and more.
• Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery.
• Drive results by owning and completing small to medium-sized projects with challenging timelines and support from their manager.
• Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment.
• Respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary.
• Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, own Corrective/Preventative Actions and associated Change Controls.
• Own and maintain process equipment assets through CMMS (preventative maintenance plans, calibration data sheets, spare parts, work order workflows).
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
• Meticulously document all activities related to manufacturing setup, troubleshooting, and automated method updates per applicable SOPs and guidelines.
• Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.
• Work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations.
• Ensure all manufacturing activities comply with health, safety, and environmental regulations.
• Support the Process Engineering On-call team with troubleshooting guidelines and investigation.
• Assist in the setup/changeover of manufacturing systems and processes.
• Perform operational assessments to ensure procedures and tools are in place.
• Participate in internal and external audits, addressing any findings, and implementing any corrective actions.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

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

• Education: BS. or M.S. in Chemical or Mechanical Engineering or equivalent

• Experience: Minimum 3 years relevant experience in Facilities, Engineering, or Operations

• Specific Certifications or Training: None

Other Quantifiable Preference:

• Experience in a GxP environment preferred.

• Self-starter with effective analytical and problem-solving skills.

• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.

• Must be able use their technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.

• 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.

• Demonstrated ability to manage own time and deliver to program timelines.

• Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.

• Familiarity with Microsoft Office Suite is required, and basic statistical analysis techniques are preferred.

• 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.

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

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

• 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
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $74,000.00 - $118,400.00. 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.

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.

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 leavesandaccommodations@modernatx.com.

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. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company's ability to obtain any required export control license.

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