Principal Software Engineer Quality Systems

at  Moderna

HERE’S WHAT YOU’LL NEED (MINIMUM QUALIFICATIONS) :

A bachelor’s degree in STEM or another relevant academic discipline.
Experience with lab systems, lab instruments or lab automation, implementing and maintaining laboratory systems, 3+ years of experience with MS degree, 5+years’ experience with BS degree and/or 9+ years combination of education and industry experience. Strong proficiency in English.
Here’s What You’ll Bring to the Table (Preferred Qualifications) :
Experience authoring and reviewing computer system validation lifecycle documents.
Experience with CFR21 Part11 and Annex 11 regulations.
Good understanding of digital network principles (segmentation, VLANs, firewall rules).
Solid experience with Microsoft Windows environments (client and server).
Good understanding of cGMP and manufacturing operations and practices.
Strong communication skills (verbal and written).
Demonstrated ability to work independently and collaboratively in cross-functional teams.
Experience with ServiceNow and System Administration activities.
Experience with Kneat validation management system.
Solid judgement with ability to make good decisions.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer) #LI-NS1

Joining Moderna offers the unique opportunity to be part of a pioneering team that’s revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you’ll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna’s commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients’ lives worldwide.
Moderna’s innovative presence in Harwell, UK, is integral to our mission of advancing mRNA technology. Our Clinical Assay Laboratory is a cornerstone in our global efforts, contributing to groundbreaking research and development. We are inviting dedicated professionals to join us in this dynamic environment where cutting-edge science meets operational excellence.
Moderna is seeking a skilled Principal Systems Engineer, Digital Lab Systems for our Harwell, England, UK location. This crucial position involves supporting and managing software solutions for laboratory equipment in Quality Control, covering the entire lifecycle of laboratory digital solutions.
Within 3 Months, You Will…
Take charge of coordinating the delivery of bench-top laboratory systems.
Independently develop and document system requirements, configuration specifications, and author System Administration SOPs in compliance with cGxP.
Execute test scripts and author critical lifecycle documentation, including Impact Assessment and ERES assessments, ensuring compliance and regulatory readiness.
Within 6 Months, You Will…
Provide robust administrative and technical support for enterprise laboratory systems such as Chromeleon, LIMS, Logilab SDMS, MODA, etc.
Perform thorough root cause analysis for operational issues and actively participate in deviation investigations to maintain system integrity.
Be a key representative for Digital Quality in system validation activities, liaising with IT, Validation, and QA for the implementation of new lab systems and their ongoing support.
Within 12 Months, You Will…
Undertake periodic reviews, supporting maintenance activities for Quality Control laboratory systems to ensure operational excellence and regulatory compliance.
Lead the implementation of system upgrades and enhancements, adapting to evolving lab requirements and technological advancements.
Represent Digital Quality expertise in internal and external audits, maintaining the highest standards of compliance and quality assurance.