Senior Engineer I, Process Engineering

ModernaTX • Norwood, MA

4d

About The Position

The candidate in this position will provide advanced technical expertise within the Global Engineering Technical Authority, supporting the design, implementation, and optimization of Drug Substance process technologies across Moderna’s global manufacturing network. This role focuses on ensuring process and equipment designs are robust, compliant, and scalable for commercial and clinical production of mRNA and lipid nanoparticle (LNP) drug substance platforms. The individual will act as a process engineering subject matter expert (SME), collaborating with cross-functional teams in R&D, MS&T, and Manufacturing to apply standardized design practices and deliver innovative solutions aligned with Moderna’s engineering and quality standards.

Requirements

• 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.

Nice To Haves

• 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.
• Strong communication and collaboration skills across functional teams and organizational levels.
• Demonstrated ability to manage multiple technical priorities within a fast-paced, matrixed environment.
• Proven problem-solving and analytical skills to identify and resolve complex technical issues.
• Commitment to data integrity, safety, and quality excellence in all work activities.

Responsibilities

• 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.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Senior