Principal, Process Engineering, Global Engineering Technical Authority

Moderna

Norwood (MA)

On-site

USD 190,000 - 230,000

Full time

9 days ago

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Job summary

Moderna in Norwood, MA, seeks a Principal Engineer, Process Engineering, to lead global technical direction for GMP drug substance manufacturing process equipment. You will guide cross‑functional teams, supervise capital projects from concept to qualification, and drive innovative technologies that improve process robustness and scalability.

The role emphasizes deep pump technologies and instrumentation expertise, with ownership for equipment design, deployment, and lifecycle optimization across

Qualifications

  • Deep expertise in biopharmaceutical process equipment and manufacturing technologies.
  • Strong background with pumps, sensors, instrumentation, and process control.
  • Experience leading technical teams and collaborating with facilities, manufacturing and development groups.

Responsibilities

  • Serve as global technical leader and SME for GMP drug substance process equipment across Moderna's network.
  • Lead cross-functional teams, provide technical guidance, and set work priorities.
  • Oversee full capital project lifecycle: design, FEED, detailed design, procurement, commissioning, and qualification.
  • Ensure projects comply with global standards, requirements, quality expectations, and regulatory rules.
  • Act as Engineering Owner for drug substance equipment, including ultrafiltration, chromatography and single‑use systems.
  • Lead lifecycle improvement and reliability across unit operations in global manufacturing.
  • Define technical direction for equipment design, optimization, and lifecycle management.
  • Evaluate and implement innovative manufacturing technologies to boost efficiency and scalability.
  • Collaborate with Research, Process Development and Manufacturing in early development stages.
  • Approve engineering design docs, specs, commissioning strategies, and qualification deliverables.
  • Design and optimize single‑use consumables and oversee supplier selection.

Skills

Biopharma equipment
Pump tech
Process instrumentation
GMP manufacturing
Cross‑functional leadership

Job description

The Role:

The Principal Engineer, Process Engineering, Global Engineering Technical Authority will be based in Norwood, MA.

The Principal Engineer, Process Engineering will serve as a global technical leader and Subject Matter Expert (SME) within Moderna's Global Engineering Technical Authority (GETA), providing technical direction, engineering oversight, and lifecycle support for GMP drug substance manufacturing process equipment across Moderna's global manufacturing network.

This individual will collaborate closely with Facilities, Manufacturing, Process Development, and other cross-functional stakeholders to design, evaluate, and implement innovative process technologies and support state-of-the‑art manufacturing capabilities.

The ideal candidate will bring strong technical expertise in biopharmaceutical process equipment, particularly pump technologies, process sensors, and instrumentation, along with a demonstrated ability to identify, evaluate, and implement emerging manufacturing technologies. This position will play an important role in advancing manufacturing capabilities, improving process robustness, and enabling the integration of new technologies into GMP manufacturing environments.

The successful candidate will demonstrate deep technical expertise, independent engineering judgment, strong problem‑solving capabilities, and a proven ability to influence cross‑functional stakeholders, mentor technical talent, and lead complex engineering initiatives.

Here’s What You’ll Do:
  • Serve as a global technical leader and Subject Matter Expert within the Global Engineering Technical Authority, providing technical direction, engineering oversight, and lifecycle support for GMP drug substance manufacturing process equipment across Moderna's global manufacturing network.
  • Lead cross‑functional teams of subject matter experts responsible for supporting drug substance manufacturing and developing engineering projects. Provide technical guidance, coaching, and work‑prioritization support across engineering teams while operating as a senior individual contributor.
  • Provide technical leadership and oversight throughout the full capital project lifecycle, including conceptual design, front‑end engineering, detailed design, equipment specification and selection, procurement, construction, installation, startup, commissioning, and qualification.
  • Ensure capital projects and equipment solutions remain aligned with global engineering standards, operational requirements, user requirements, quality expectations, and applicable regulatory requirements.
  • Serve as the global technical SME and Engineering Owner for drug substance process equipment, including ultrafiltration systems, chromatography systems, single‑use mixers, Clean‑in‑Place systems, temperature control units, reaction vessels, and associated equipment.
  • Act as Engineering Owner for assigned process equipment, providing technical stewardship from initial design and implementation through operation, optimization, and lifecycle improvement.
  • Establish technical direction for the design, optimization, and lifecycle management of drug substance manufacturing unit operations, driving consistent engineering practices, equipment reliability, process robustness, and continuous improvement across Moderna's global manufacturing network.
  • Bring deep technical expertise in pump technologies and process instrumentation, including the evaluation, selection, design integration, troubleshooting, and optimization of pumps, sensors, instrumentation, and associated process‑control components used in biopharmaceutical manufacturing.
  • Drive the identification, technical evaluation, and strategic implementation of innovative manufacturing technologies that improve process efficiency, equipment reliability, scalability, and operational performance.
  • Assess emerging manufacturing technologies through technical feasibility studies, engineering evaluations, and collaboration with equipment and technology suppliers. Develop implementation recommendations based on process requirements, GMP suitability, technical risks, scalability, and operational benefits.
  • Partner closely with Research, Process Development, and Manufacturing teams during early stages of process development to evaluate new manufacturing technologies and support the selection of scalable, robust, and GMP‑compatible solutions.
  • Lead complex engineering evaluations, technical studies, troubleshooting activities, and equipment performance assessments, translating findings into clear technical recommendations and guiding implementation of solutions that strengthen manufacturing capability, reliability, and process performance.
  • Provide technical oversight and approval of engineering design documentation, equipment specifications, commissioning strategies, and qualification deliverables within delegated authority.
  • Design and optimize single‑use consumables, ensuring functional requirements are clearly defined and that supplier select
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