Engineer II, Quality Assurance

The Role:

ModernaTX, Inc. seeks an Engineer II, Quality Assurance for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• Support manufacturing improvement initiatives and technology transfer projects.

• Author, review, and approve Standard Operating Procedures (SOPs), policies, and batch production/testing records to ensure compliance and adherence to regulations and cGMP operations.

• Troubleshoot manufacturing issues and evaluate solutions.

• Identify, classify, and report deviations.

• Oversee execution of remediation and Corrective Action Preventative Action (CAPA) activities required to continue production and/or move a process to the next milestone.

• Work with team to determine root cause and potential preventative/corrective actions.

• Ensure timely closure of investigations.

• Provide quality oversight to the change management system for change controls related to new product introduction and major process changes, including providing plan creation oversight, verifying that changes adhere to SOPs, and regulatory compliance.

• Partner with peers and cross-functional teams for process changes.

• May telecommute up to 1 day per week.

Here’s What You’ll Bring to the Table:

• Minimum requirements:

• Requires a Master’s degree in Mechanical Engineering, Manufacturing Engineering, or related field and 1 year of experience as a Manufacturing Associate, Manufacturing Process Associate, Validation Engineer, or related position.

• 1 year of experience must include:

• Quality Assurance & Regulatory Compliance support;

• Change controls;

• Change Management and CAPA;

• Analyzing & developing solutions for manufacturing issues; and

• cGMP practices.

• May telecommute up to 1 day per week.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17234) or email resume and cover letter to [email protected] with subject line: R17234.

#DNI

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 [email protected]. (EEO/AAP Employer) 

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