Senior Engineer I, Process Engineering

The Role 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. Here’s What You’ll Do 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. Here’s What You’ll Need (Basic Qualifications) 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. Here’s What You’ll Bring to the Table (Preferred Qualifications) 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. Pay & 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. The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. 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 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 View email address on click.appcast.io. 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. #J-18808-Ljbffr Dormont Manufacturing Co