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12 часов назад

Sr Principal Eng, Process Engineering (API Manufacturing)

122 000 - 212 750$
Формат работы
hybrid/onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Belgium
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
Sr Principal Eng, Process Engineering (API Manufacturing): Leading the design, optimization, and technical strategy of synthetic drug substance manufacturing processes with an accent on API unit operations, process safety, cGMP compliance, and equipment selection. Focus on scaling and transferring processes from pilot to commercial production, applying digital manufacturing solutions, and solving complex purification, solid-state, and particle-engineering challenges across global sites.

Location: Athens, Georgia, United States; this is an onsite/hybrid role. The position is also available under a Belgium requisition.

Base pay: $122,000–$212,750 per year.

Company

Johnson & Johnson develops healthcare, Innovative Medicine, and MedTech solutions focused on preventing and treating complex diseases.

What you will do

  • Lead the intake, scoping, prioritization, and resolution of technical requests for synthetic drug substance manufacturing across global sites.
  • Direct early-phase process design, technology selection, scope definition, capital planning, and schedule development for API manufacturing projects.
  • Provide expertise in chemical reactions, phase separation, distillation, solvent exchange, crystallization, filtration, centrifugation, drying, milling, and blending.
  • Drive robust, standardized, inspection-ready API processes aligned with cGMP, ICH Q7, product quality, process safety, and regulatory expectations.
  • Advance digital and data-enabled manufacturing through real-time monitoring, advanced process control, analytics, modeling, simulation, and smart manufacturing.
  • Collaborate with R&D/CMC, MSAT, Quality, EHS, Operations, external manufacturers, and other stakeholders to resolve issues and implement reliable solutions.

Requirements

  • Master’s degree or equivalent experience in Engineering, Pharmaceutical Sciences, or a related technical field.
  • At least 10 years of relevant experience in synthetic drug substance or API manufacturing.
  • Expertise in API purification and solid-state or particle engineering, including crystallization, filtration/centrifugation, drying, and milling.
  • Experience with API scale-up, technology transfer, process fixing, reactor systems, solvent handling, and process controls from pilot to commercial scale.
  • Strong knowledge of cGMP environments, regulatory expectations, data integrity, documentation, process safety, and API manufacturing equipment.
  • Proficiency in written and spoken English is required; willingness to travel up to 25% domestically and internationally is required.

Nice to have

  • Experience with containment design for potent materials, dust control, contained transfer, and exposure mitigation.
  • Experience with PI/data historians, manufacturing data, and smart manufacturing systems.
  • Additional Dutch, Spanish, or Italian language skills.
  • Strong customer management, communication, strategic thinking, and cross-functional influencing skills.

Culture & Benefits

  • Work with global, multifunctional engineering teams across multiple sites and functions.
  • Opportunities to influence API technology direction, standardization, and capability building across the manufacturing network.
  • Retirement pension and 401(k) savings plans.
  • Vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.
  • Inclusive work environment and accommodations during the interview process.

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