Sr. GxP Automation Engineer

at  Moderna

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

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