QC Principal Engineer, Quality Control

1 month ago

Norwood, Massachusetts, United States Moderna, Inc. Full time

The Role:

This individual contributor role involves leading the global implementation and maintenance of laboratory automation and robotics across Modernas 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.

Heres What Youll 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. Heres What Youll 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 Heres What Youll 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 robots, automated refrigeration units (Hamilton BIOs, SAM HD, Azenta Biostore, etc.) autonomous mobile robots, automated inventory management, and other cutting-edge laboratory technologies. Demonstrated innovative mindset, with a proactive approach in identifying opportunities for improvement and taking the initiative to drive change. Validated ability to deliver on tight timelines with pragmatic solutions, leveraging strong project management skills to ensure all automation projects are completed efficiently and effectively. This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work. 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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 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. Were 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 (EEO/AAP Employer)

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