Sr. GxP Automation Engineer
ModernaTX, Inc.

The Role

As a Senior GxP Automation Engineer at Moderna, you will play a crucial part of our manufacturing operations, supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems. These systems include, but are not limited to Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, AVEVA Historian, Apprentice MES and OSIsoft PI. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise in automation to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

The ideal candidate for this role will have experience in spinning up new facilities and experience with pre-filled syringe manufacturing, although these are not a must-have in the role if you are a strong GxP Automation Engineer with a wide variety of system experience.

Here's What You'll Do

In this role, your responsibilities will include:

• Taking an active lead role during the construction, CSV/CQV and overall delivery of the manufacturing facility.
  
• Troubleshooting complex issues within our GxP manufacturing systems, such as Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, and AVEVA Historian, ensuring their smooth and efficient operation.
  
• Coordinating maintenance activities across different systems and teams, ensuring the continuity and quality of our manufacturing processes.
  
• Maintaining and sustaining a culture of compliance both in how we design solutions and in how we run and maintain operations.
  
• Serving as a change agent to engage and educate the business owners on the capability and functionality of the solutions.
  
• Coordinating validation activities in collaboration with Manufacturing, Engineering, Validation, and QA.
  
• Developing and maintaining GMP system documentation and manage supporting compliance activities.
  
• Leading / overseeing investigations, CAPAs, deviations and change controls.
  
• Supporting regulatory, partner and internal audits.
  
• Performing other administrative/managerial duties as required.
  

Here's What You'll Need (Minimum Qualifications)

• Bachelor of Science degree in Engineering, Computer Science, or a related technology discipline.
  
• Minimum of 7 years of experience in a similar role within the biotech or related industry.
  
• Strong knowledge of computer systems validation and GMP regulations.
  
• 2+ years of experience with Allen Bradley PLCs and Wonderware System Platform.
  

Here's What You'll Bring to the Table (Preferred Qualifications)

• Experience with PFS (prefilled syringe) manufacturing.
  
• Experience with new start-up facilities.
  
• Experience in dealing with multiple projects and working in a multi-disciplinary team, managing multiple tasks/assignments with staggered due dates and deadlines.
  
• Experience with Manufacturing Filling or Packaging equipment
  
• Demonstrated ability to make crisp decisions in a dynamic, fast-paced environment and build collaborative relationships with colleagues and business partners.
  
• Clear communication skills, with the ability to convey complex information in an understandable manner to various stakeholders.
  
• Experience supporting various digital manufacturing systems including MES and Historian.
  
• Experience working in an operational GxP facility, demonstrating a strong understanding of the regulations and standards in this environment.
  
• Proficiency in IT/OT networking, with the ability to troubleshoot and optimize.
  
• Understanding of biopharmaceutical processes and equipment.
  
• Ability to quickly adapt and learn new skills and technologies.
  
• 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)

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