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9 дней назад

Principal Engineer, Drug Product, Global Engineering Technical Authority

142 500 - 256 500$
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
Principal Engineer, Drug Product, Global Engineering Technical Authority (Sterile Manufacturing): Leading global technical standards and capital projects for sterile drug product filling, packaging, labeling, and closing equipment with an accent on GMP compliance, validation, qualification, and equipment lifecycle execution. Focus on building a Technical Authority organization, solving complex equipment and process challenges, and standardizing engineering practices across global manufacturing sites.

Location: Norwood, Massachusetts, United States; 100% onsite. Only U.S. persons—U.S. citizens, permanent residents, asylees, or refugees—are eligible because of U.S. export control requirements.

Salary: $142,500–$256,500 per year, with potential discretionary bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines, with a focus on scientific progress and changing how medicines are created and delivered.

What you will do

  • Build and lead a global Technical Authority organization for drug product manufacturing operations.
  • Serve as the global subject matter expert for sterile filling, closing, primary and secondary packaging, labeling, and vision inspection equipment.
  • Lead capital project execution from front-end engineering and design through procurement, construction, installation, commissioning, validation, and qualification.
  • Develop equipment specifications, user requirements, engineering standards, turnover packages, and vendor assessment processes.
  • Lead FAT, SAT, commissioning, qualification, troubleshooting, deviation investigations, change controls, and regulatory audit support.
  • Drive technology innovation, machine recipe optimization, preventive maintenance, and continuous improvement across global manufacturing sites.

Requirements

  • Bachelor’s or Master’s degree in Engineering or a related technical field; an advanced degree is preferred.
  • 15+ years of engineering experience in the pharmaceutical industry, specifically with drug product manufacturing equipment.
  • Deep knowledge of sterile manufacturing requirements and experience with GMP, FDA, ICH, EMA, FAT, SAT, commissioning, validation, and qualification.
  • Experience managing large-scale global capital projects, equipment vendors, and cross-functional technical teams.
  • Strong leadership, communication, problem-solving, and stakeholder-influencing skills.
  • Must work onsite in Norwood, Massachusetts and qualify as a U.S. person under applicable export control laws.

Culture & Benefits

  • In-person, site-based working model focused on direct collaboration, mentorship, and hands-on partnership.
  • Competitive healthcare and voluntary benefit programs.
  • Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
  • Savings and investment programs plus location-specific perks.
  • Smoke-free, alcohol-free, and drug-free work environment.

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