Associate GxP Systems Engineer at Moderna, Inc.

The Role

Moderna is seeking an Associate Systems Engineer who will serve a key role supporting the Validation, Delivery and Administration of the GxP laboratory benchtop computerized systems and Enterprise systems. The individual will assist in troubleshooting issues with the systems, update configuration, assist with deployment of systems, participate in generating and maintaining necessary supporting applications, documents, and procedures. Activities will also include authoring and executing test protocols.

You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. You thrive in a fast-paced environment and are comfortable rolling up your sleeves if a process doesnt exist yet, you define it. You collaborate well amongst a team of expert peers.

Heres What Youll Do

• As part of the GxP Systems team, you will assume responsibility of supporting Modernas QC computerized Lab Benchtop and Enterprise systems.

• Drive system validation activities in conjunction with Business, IT, Equipment, Validation and QA partners to implement new systems, perform system life cycle upgrades, and break fixes required as part of incidents.

• Work independently to author/update System Configuration/Design Specifications, System Administration SOP, execute test scripts following cGxP.

• Review and approve lifecycle documents like impact assessment, regulatory applicability, and criticality assessments, ERES assessments etc.

• Provide support to the QC labs for the Benchtop and Enterprise computer systems as system administrator.

• Be the first point of contact with Business and help resolve incident tickets.

• Fulfill access requests for Enterprise computer systems.

• Assist with incidents requiring troubleshooting and be the subject matter expert to investigate, troubleshoot, find resolution, and implement the resolution.

• Generate Periodic Reviews for the systems and assist in periodic reviews performed by other SMEs.

• Work with the Lab Automation team to interface the standalone systems with our SDMS and LIMS as required.

• Assists in evaluation or product enhancements and capabilities as required.

• This position may require working in morning or afternoon shift and one weekend day coverage is required but is a flexible position for some remote work.

• Additional duties as may be assigned from time to time.

Heres What Youll Need (Basic Qualifications)

• A bachelors degree in STEM or another relevant academic discipline

• A minimum of 6 years with a MS degree, or 8+ with a bachelors degree; a combination of education and experience may be considered.

• Experience authoring and reviewing computer system validation lifecycle documents.

• Prior experience in working in a controlled cGxP environment.

• Experience with Document Management, QMS, ServiceNow and System Administration activities.

• Experience authoring and executing validation lifecycle deliverables.

• Experience writing change controls and deviations/CAPAs utilizing GxP workflows.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Experience with Benchtop lab computerized systems like TOC, Bioanalyzers, Spectramax/Softmax etc.

• Experience with Enterprise Instrumentation Systems such as Chromeleon Chromatography Data System, Mettler LabX, etc. is preferred.

• Experience working in life sciences, pharma/biotech, or high-tech industries with a preference for experience in one or more of eCommerce, data/machine learning platforms, or cloud infrastructure.

• Experience in a regulated environment

• Experience working in a matrixed organization.

• Experience working in a fast-paced environment requiring quality contribution on multiple critical projects.

• Demonstrated ability to work independently and collaboratively in cross-functional teams and open to learn and adapt to changing demands.

• Strong communication skills (verbal and written)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• Experience working with laboratory instrumentation connectivity and data.

• Familiarity with Computer Systems Validation standards and deliverables.

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
• Generous 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 thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-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 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. 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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