Associate Cyber Security Engineer

Location Type: On-site

 

The Role:

ModernaTX, Inc. seeks an Associate Cyber Security Engineer for its Cambridge, Massachusetts location.

Here’s What You’ll Do:

• Develop and revise the global Systems Development Lifecycle (SDLC) policies and procedures to ensure governance and standardization of customized software and applications to support various systems within Moderna’s functions.
• Ensure data integrity prioritization in the design, delivery, and maintenance of the SDLC.
• Manage SDLC activities of Good Practice (GxP) Systems/Assets by performing regulatory compliance assessment and creating Computer System Validation (CSV) deliverables, addressing inquiries and providing direction for regulatory compliance.
• Evolve SDLC processes and guidelines adaptions to accommodate different delivery models, such as Agile and V-Model, and projects of varying size and scope.
• Support Digital Project Teams on system implementation and operational elements under the SDLC, and address inquiries and provide direction on adherence.
• Create, curate, standardize tools, training materials, templates and best practices that are current, relevant, and consistent with the SDLC program expectations.
• Monitor regulatory and industry trends to ensure required changes in compliance policies, procedures and testing are integrated into existing procedures in a timely manner.
• Identify, devise, and recommend new opportunities to optimize current processes.
• Engage and educate digital and cross-functional areas on SDLC governance and tools functionality.
• Communicate status of Digital Quality Records to Site, Department, and Quality leadership on a continuous basis to ensure that all functional areas within GxP Digital adhere to the agreed Performance Indicators.
• Manage Quality Records by tracking aging records and conducting weekly meetings to drive timely closures, assessing the business and regulatory impact of Aging records to ensure business continuity, patient safety, and compliance.
• 20% domestic travel required.
• May telecommute up to 30% of the time.

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

Minimum requirements:

• Requires a Bachelor’s degree, or foreign equivalent, in Biotechnology, Biomedical Engineering, or related field and 5 years of experience as a Business Systems Analyst, Validation Analyst, Associate Analyst, or related position involving implementation of GxP systems.
• 5 years of experience must include:
  • SDLC for GxP computer systems;
  • GxP Change Management;
  • GxP Data Integrity;
  • Computer System Validation;
  • Ensuring compliance with pharmaceutical industry regulations including 21 CFR Part 11, EU Annex 11, Japanese ERES, GDPR regulations, & FDA cGMP guidelines; and
  • Conducting impact assessments.
• 20% domestic travel required.
• May telecommute up to 30% of the time.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R18143) or email resume and cover letter to careers@modernatx.com with subject line: R18143.

#DNI

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

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.

Our Working Model

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

#LI-NB1