Senior Engineer I, Process Engineering
Description
This role involves providing advanced technical expertise in Global Engineering Technical Authority, focusing on the design, implementation, and optimization of Drug Substance process technologies across Moderna's global manufacturing network. The individual will ensure robust, compliant, and scalable process and equipment designs for commercial and clinical production of mRNA and LNP drug substance platforms. They will act as a process engineering subject matter expert (SME), collaborating with cross-functional teams to apply standardized design practices and deliver innovative solutions aligned with Moderna's engineering and quality standards.
What We're Looking For
Serve as a technical SME for key Drug Substance processes (IVT, Chromatography, TFF, LMX, LNP formulation).,Support the design, scale-up, and implementation of modular and small-scale process skids in alignment with GxP requirements.,Participate in the development of PFDs, P&IDs, URS, and FRS for Drug Substance manufacturing systems.,Contribute to Clean-In-Place (CIP) system design and optimization.,Collaborate with internal stakeholders and vendors on equipment design specifications and automation strategies.,Support root cause investigations, deviation analysis, and continuous improvement projects.,Contribute to technical reviews, design evaluations, and standardization initiatives.,Ensure compliance with GxP/GMP regulations and Moderna's quality and documentation systems.,Maintain required training, documentation, and audit readiness.,Mentor junior engineers and contribute to continuous improvement within Global Engineering.
Ideal Candidate
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Minimum Education
Bachelor's Degree (Master's preferred)
Hard Skills
Soft Skills
Benefits
Special Commitments
Position is site-based, requiring full-time presence at Moderna's site.,Not eligible for remote work.,Requires adherence to Moderna's 70/30 work model (70% in-office).,May involve access to U.S. export control laws technology/data; employment contingent on ability to access export-controlled information.,Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible due to export control regulations.,Moderna is unable to sponsor non-U.S. persons for an export control license for this role.
About the Company
Moderna, Inc.
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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