QC Principal Engineer, Quality Control

The Role:

This individual contributor role involves leading the global implementation and maintenance of laboratory automation and robotics across Moderna’s Quality Control (QC) laboratories. The incumbent will be responsible for the project planning, coordinating implementation, and management of automated systems including Hamilton liquid handlers, Andrew+ pipetting robots, automated refrigeration units, autonomous mobile robots, automated inventory management, and other cutting-edge robotics. The incumbent will work in a highly collaborative, cross-functional team environment, working closely with our Technical Development, Digital/IT, QA, Manufacturing, Analytical Development, Analytical Science and Technology, and Regulatory organizations. This collaboration will involve providing strategic direction and guidance on robust and efficient laboratory automation programs, systems, policies, and standards in a GMP environment. The incumbent will also be responsible supporting regulatory and third-party inspections, and providing technical support for troubleshooting and automation-related investigations. 

Here’s What You’ll Do:  

• Contributing to the strategic planning and development of the global roadmap for laboratory automation and robotics.

• Driving weekly governance meetings including deck creation and organization of all workstream updates to present at high level meetings including steering committee and quarterly business reviews.

• Enhancing the design, implementation, and management of automated laboratory systems such as Hamilton liquid handlers, Andrew+ pipetting robots, automated refrigeration units (Hamilton BIOs, SAM HD, Azenta Biostore, etc), autonomous mobile robots (AMR), and automated inventory management.

• Working closely with the business owners for QC systems like Chromeleon, LES, LabVantage LIMS, LabX, MODA, etc., to ensure smooth integration and optimal use of these systems within the automated laboratory environment.

• Developing appropriate standard operating procedures, automated data collection, and documentation systems for new and existing laboratory automation systems, ensuring cGMP compliance.

• Ensuring QC automation processes and policies/standards are established, implemented, audited, and continuously improved to ensure cGMP compliance with global regulations.

• Overseeing data analytics, monitoring, and trending for release and stability programs, and ensuring the accuracy and integrity of data generated from automated systems.

• Providing QC technical support for internal testing sites and product-related inspections, including troubleshooting and resolving automation-related issues.

• Driving the improvement of laboratory automation processes and systems to increase efficiency, reduce errors, and increase throughput.

• Development and implementation of QC performance metrics for automation, tracking the performance and reliability of automated systems, and using this data to drive continuous improvement.

• Supporting CMC deliverables, providing technical QC support to manufacturing and quality during manufacturing and/or QC investigations involving automated systems.

• Provide guidance and direction in alignment with organizational strategies and priorities.

• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.

• Staying updated on the latest trends in laboratory automation, bringing innovative ideas and solutions to the table to continually advance our automation capabilities.

• Actively contributing to the vision of a fully automated lab, ensuring all initiatives and projects align with this strategic goal.

• Provide guidance and input in alignment with organizational strategies and priorities.

• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement. Ensure efficient utilization of resources (people, facilities, supplies) to meet production timelines.

Here’s What You’ll Need:  

• Education: BS, MS, or PHD in a relevant scientific/engineering discipline.

• Experience:  10+ years’ of experience in automation experience in design and implementation

• Specific Certifications or Training: None 

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

• Solid knowledge of GMP regulations and Computer Systems Validation (CSV), with the ability to apply this understanding effectively in the context of laboratory automation.

• Proven experience in implementing and managing automated systems including Hamilton liquid handlers, Andrew+ pipetting ro