Engineer II, Manufacturing Process Engineer - Moderna, Inc.

The Role

In this role, you will be responsible for supporting the day-to-day operations of our cutting-edge manufacturing processes at Norwood. This role will be instrumental in reducing manufacturing events, minimizing user interventions, and enhancing product quality and safety standards through direct engineering support, troubleshooting acumen, and continuous improvement initiatives. Your expertise will not only ensure the smooth and efficient production of our products but also drive the innovation and optimization of our manufacturing space. Applicants should have a blend of technical expertise, problem-solving skills, and a collaborative spirit to support our mission and contribute to our growth in a fast-paced, multiproduct environment.

Heres What Youll Do

• Provide direct engineering support for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc) to reduce manufacturing events, user interventions and batch record alerts.

• Manufacturing Support: Assist in the setup/ changeover of manufacturing systems and processes. Provide hands-on support to ensure equipment and machinery are functioning optimally. Perform operational assessments to ensure procedures and tools are in place.

• Troubleshooting & Triage: Act as the first point of contact for any manufacturing issues. Quickly diagnose and resolve technical problems independently to minimize downtime. Determine root cause of failure modes, with support from Process Engineering System Owners for more complex issues.

• Automated Method Updates: Responsible for all automated method updates of processing equipment in the manufacturing space. This includes developing and implementing updates for both new product introductions and enhancements to existing product functionalities, ensuring seamless integration and minimal disruption to ongoing operations.

• Process Optimization: Continuously monitor production processes to identify improvements that increase efficiency, reduce waste, and improve quality and support continuous improvement efforts with Process Engineering System Owners.

• Documentation: Meticulously document all activities related to manufacturing setup, troubleshooting, and triaging, and automated method updates per applicable SOPs and guidelines.

• Quality: Work closely with the Quality Assurance team to ensure that all manufacturing processes meet internal and external regulatory requirements via support of deviation initiation, CAPAs and out-of-tolerance investigations related to instrument calibrations.

• Training: Provide training and guidance to manufacturing staff on new equipment, processes, and troubleshooting techniques. Drive learning between MFG and F&E.

• Safety Compliance: Ensure all manufacturing activities are conducted in accordance with health, safety, and environmental regulations.

• On-Call: Support the process engineering on call team and provide updated guidelines for troubleshooting.

• Additional duties as may be assigned from time to time.

Heres What Youll Need (Minimum Qualifications)

• Minimum Education Requirement: A bachelors degree in chemical engineering, mechanical engineering, or related field.

• Minimum of 2 years of relevant experience as a Process Engineer, Manufacturing Engineer, or related role.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Minimum of 2 years of experience in a GMP environment preferred.

• Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc)

• Strong analytical and problem-solving skills.

• Ability to excel in a fast paced, multiproduct environment.

• 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 leadership decisions. Technical writing skills required.

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

• Proven ability to multitask.

• Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.

• 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 Modernas 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.

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 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. 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

-