Senior GxP Automation Engineer

7 hours ago

Norwood, Massachusetts, United States BioSpace, Inc. Full time
About the Role

We are seeking a highly skilled Sr. GxP Automation Engineer to join our team at Moderna. As a key member of our manufacturing operations, you will play a crucial part in supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems.

Key Responsibilities
  • Take an active lead role during the construction, CSV/CQV, and overall delivery of the manufacturing facility.
  • Troubleshoot complex issues within our GxP manufacturing systems, ensuring their smooth and efficient operation.
  • Coordinate maintenance activities across different systems and teams, ensuring the continuity and quality of our manufacturing processes.
  • Maintain and sustain a culture of compliance both in how we design solutions and in how we run and maintain operations.
  • Serve as a change agent to engage and educate the business owners on the capability and functionality of the solutions.
  • Coordinate validation activities in collaboration with Manufacturing, Engineering, Validation, and QA.
  • Develop and maintain GMP system documentation and manage supporting compliance activities.
  • Lead/oversee investigations, CAPAs, deviations, and change controls.
  • Support regulatory, partner, and internal audits.
  • Perform other administrative/managerial duties as required.
Requirements
  • 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.
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.
About Moderna

Moderna is a leading biotechnology company that is pioneering the development of mRNA-based therapies and vaccines. We are committed to delivering innovative solutions that transform the lives of patients worldwide.

We are proud to offer 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.

We are committed to creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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