Senior Engineer I, Process Engineering

Serve as a technical SME for key Drug Substance processes, including In Vitro Transcription (IVT), Chromatography, Tangential Flow Filtration (TFF), Lipid Mixing (LMX), and Lipid Nanoparticle (LNP) formulation.,Support the design, scale-up, and implementation of modular and small-scale process skids in alignment with GxP requirements and Moderna's global standards.,Participate in the development of process flow diagrams (PFDs), P&IDs, User Requirement Specifications (URS), and Functional Requirement Specifications (FRS) for Drug Substance of manufacturing systems.,Contribute to Clean-In-Place (CIP) system design and optimization, focusing on process safety, efficiency, and reliability.,Collaborate with internal stakeholders and vendors to ensure equipment design specifications and automation strategies meet performance, quality, and safety objectives.,Support root cause investigations, deviation analysis, and continuous improvement projects to enhance process performance and reliability.,Contribute to technical reviews, design evaluations, and standardization initiatives under Moderna's Technical Authority governance model.,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 the continuous improvement of technical and operational excellence within Global Engineering.

Education: Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related field required. Master's degree preferred.,Experience: Minimum of 7–10 years of experience in process engineering or manufacturing science roles in a biopharmaceutical, biotechnology, or sterile manufacturing environment.,Hands-on experience with Drug Substance processes such as IVT, chromatography, TFF, and LNP systems.,Proven ability to support process design and equipment specification in a regulated manufacturing setting.,Demonstrated experience in process simulation and modeling (e.g., mass and energy balances, scale-up modeling, dynamic or steady-state process simulation) to support process design, capacity analysis, and technology transfer.,Familiarity with bioprocess skid design, automation, and process analytical technologies (PAT).,Experience supporting or leading cross-functional technical projects.,Exposure to personalized medicine or individualized manufacturing processes (e.g., INT).,Certifications/Training: GxP/GMP compliance training.,Strong understanding of FDA, EMA, and ICH regulations.

Bachelor's Degree

Must be a U.S. person (citizen, permanent resident, asylee, or refugee) due to export control laws; Moderna is unable to sponsor non-U.S. persons for an export control license.