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11 дней назад

Senior Engineer I, Process Engineering (mRNA/LNP)

109 200 - 174 600$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Engineer I, Process Engineering (mRNA/LNP): Designing, scaling, and implementing drug substance process technologies and manufacturing equipment for mRNA and lipid nanoparticle platforms with an accent on GxP compliance, process modeling, and robust equipment design. Focus on developing PFDs, P&IDs, URS and FRS documents, optimizing CIP systems, investigating process deviations, and supporting reliable commercial and clinical production.

Location: Norwood, Massachusetts, United States. Only individuals who qualify as U.S. persons are eligible; non-U.S. persons cannot be sponsored for an export control license.

Salary: $109,200–$174,600 per year, with potential eligibility for a discretionary bonus, incentive compensation, or equity award.

Company

hirify.global develops mRNA technology platforms and medicines for clinical and commercial use.

What you will do

  • Provide technical subject matter expertise for drug substance processes including IVT, chromatography, TFF, lipid mixing, and LNP formulation.
  • Design, scale up, and implement modular and small-scale process skids in accordance with GxP requirements and global engineering standards.
  • Develop PFDs, P&IDs, URS, and FRS documentation for drug substance manufacturing systems.
  • Design and optimize CIP systems, equipment specifications, and automation strategies with internal stakeholders and vendors.
  • Support root cause investigations, deviation analysis, continuous improvement, technical reviews, and standardization initiatives.
  • Maintain audit readiness, documentation, and training requirements while mentoring junior engineers.

Requirements

  • Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related field; a master’s degree is preferred.
  • 7–10 years of experience in process engineering or manufacturing science within biopharmaceutical, biotechnology, or sterile manufacturing environments.
  • Hands-on experience with IVT, chromatography, TFF, and LNP drug substance processes.
  • Experience designing processes and specifying equipment in regulated manufacturing environments.
  • Experience with process simulation and modeling, including mass and energy balances, scale-up modeling, and dynamic or steady-state simulation.
  • Must qualify as a U.S. person under U.S. export control laws; visa sponsorship for non-U.S. persons is unavailable.

Nice to have

  • Experience with bioprocess skid design, automation, and process analytical technologies.
  • Experience leading cross-functional technical projects or supporting personalized medicine and individualized manufacturing.
  • Training in GxP/GMP compliance and knowledge of FDA, EMA, and ICH regulations.

Culture & Benefits

  • Healthcare coverage and voluntary benefits programs.
  • Fitness, mindfulness, and mental health resources.
  • Family planning support, including fertility, adoption, and surrogacy benefits.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
  • Savings and investment programs, plus location-specific benefits.

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