Engineer III, Process Development

## Engineer III, Process Development Apply locations:
Norwood, Massachusetts:
Technical Development time type:
Full time posted on:
Posted Todayjob requisition :
R19302
** The Role
** Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. We are seeking a highly skilled and motivated Individual to join Moderna’s Technical Development organization in Norwood,  this role, you will support the development of manufacturing processes for Moderna’s mRNA-based medicines to enable clinical and commercial supply, with a focus on process understanding and process control strategy definition, and the transfer of established RNA production processes into fully integrated, automated, next-generation manufacturing systems.

The ideal candidate will combine deep expertise in RNA manufacturing with a systems-level mindset, enabling the design and implementation of next-generation equipment and end-to-end production workflows. The individual will act as a 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 RNA manufacturing processes (e.g. IVT, purification) and translate processes into detailed functional and technical requirements for automated systems.
* 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.
* Support the design, scale-up, and implementation of modular and small-scale process skids in alignment with GxP requirements and Moderna’s global standards.
* Partner with engineering, automation, and equipment vendors to design novel manufacturing platforms that enable closed and continuous operations that meet performance, safety, regulatory, and data integrity requirements.
* Contribute to Clean-In-Place (CIP) system design and optimization, focusing on process safety, efficiency, 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.
* Support global site startup activities via tech transfer, process investigations and provide person-in-plant support may require domestic or international travel (up to 15% of working time).
** Here’s What You’ll Need (Basic Qualifications)
*** BS or MS in chemical engineering, biological engineering, chemistry, biochemistry, or closely related field
* BS with 5+ years, or MS with 2+ years of relevant industry experience in bioprocess development, pharmaceutical development, or closely related area
* Hands-on experience with chromatography, ultrafiltration, normal flow filtration, and/or development of innovative unit operations or experience in nucleic acid drug development (DNA, RNA, oligonucleotides) and/or nanoparticle delivery.
* Experience in designing, executing, and analyzing scientific experiments
* Proven ability to support process design and equipment specification in a regulated manufacturing setting.
** Here’s

What You’ll Bring to the Table (Preferred Qualifications)
*** Experience in technology transfer and optimization of manufacturing processes.
* 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
* 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.
**…