Associate Cyber Security Engineer

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.

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