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6 дней назад

Senior Engineer I, Manufacturing Sciences and Technology (Pharmaceutical Manufacturing)

109 200 - 174 600$
Формат работы
hybrid
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, Manufacturing Sciences and Technology (Pharmaceutical Manufacturing): Leading material lifecycle strategy and manufacturing support for consumables and raw materials with an accent on GMP systems, unit operations, supplier changes, and technology transfer. Focus on solving process and equipment issues, preparing regulatory submissions, aligning Extractables and Leachables strategies, and applying approved Generative AI tools to technical documentation.

Location: Norwood, Massachusetts, United States; hybrid 70/30 work model with 70% in-office collaboration. Only U.S. persons eligible due to U.S. export control requirements.

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

Company

hirify.global develops mRNA technology platforms and medicines to transform healthcare.

What you will do

  • Provide technical leadership across the lifecycle of consumables and raw materials, including new material introduction, consumable design, investigations, supplier change assessments, scale-up, and technology transfer.
  • Improve material introduction processes and establish robust unit operations and long-term material strategies aligned with manufacturing needs.
  • Troubleshoot process and equipment issues, lead internal and supplier deviation investigations, and implement corrective and preventive actions.
  • Lead supplier change impact assessments and coordinate technical collaboration with suppliers and internal stakeholders.
  • Prepare BLA and MMA submissions, including clinical and non-clinical overviews, summaries, clinical study reports, and other CTD modules.
  • Drive critical materials improvement, global testing strategies, and aligned Extractables and Leachables strategies across sites in partnership with Technical Development, Supply Chain, Procurement, Quality, and Regulatory Affairs.

Requirements

  • BS or MS in mechanical engineering, material science, or a related technical discipline.
  • At least 5 years of industry experience in process development, manufacturing, engineering, or a similar technical role; 8–12 years preferred.
  • Ability to develop a strong understanding of GxP and GMP regulations.
  • Experience or capability in GMP quality systems, processing equipment, unit operations, pharmaceutical manufacturing regulatory guidelines, technical investigations, supplier assessments, and technology transfer.
  • Strong communication skills for leading technical teams and coordinating across functions.
  • Ability to follow SOPs, work instructions, Good Documentation Practices, Data Integrity requirements, cGMP, EHS, regulatory, and company requirements.
  • Ability to complete required training and requalification activities within defined timelines.
  • For export-controlled work, eligibility as a U.S. person: citizen, permanent resident, asylee, or refugee.

Culture & Benefits

  • In-person collaboration supported through a 70/30 work model with direct teamwork and mentorship.
  • Healthcare and voluntary benefit programs, plus fitness, mindfulness, and mental health resources.
  • Family planning support including fertility, adoption, and surrogacy benefits.
  • Paid time off including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
  • Savings and investment programs, location-specific perks, and a smoke-free, alcohol-free, and drug-free workplace.

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