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15 часов назад

Process Engineer in Fill Finish Fill Operations (Sterile Manufacturing)

54 800 - 73 067
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Ireland
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
Process Engineer in Fill Finish Fill Operations (Sterile Manufacturing) (GMP manufacturing): Leading batch release activities and process engineering improvements across thawing, formulation, filling, filter integrity testing, and wash/autoclave operations with an accent on sterile manufacturing, documentation, and quality compliance. Focus on root cause analysis, CAPA closure, deviation management, cycle development, change controls, and solving operational problems in a 24/7 production environment.

Location: Waterford, Ireland; on-site. 24/7 shift pattern: 2 days, 2 nights, 4 days off, with 12-hour shifts.

Salary: €54,800–€73,067 per year.

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines.

What you will do

  • Lead and deliver batch release-related activities for fill-finish operations.
  • Conduct investigations, root cause analysis, CAPA generation and closure, work order investigations, and resolution of batch comments.
  • Develop and implement continuous improvement initiatives across thawing, formulation, filling, filter integrity testing, and wash/autoclave operations.
  • Execute cycle development protocols and reports, deviation management, problem solving, and change controls.
  • Support commercial manufacturing by delivering SQDCI performance metrics.
  • Provide leadership and operational support while maintaining quality and safety standards.

Requirements

  • Degree in an engineering discipline.
  • Strong problem-solving skills.
  • Strong documentation, protocol generation, and protocol execution skills.
  • Relevant experience in a highly regulated GMP environment.
  • Experience in sterile manufacturing operations.
  • Availability for on-site 24/7 work in Waterford, Ireland, on 12-hour shifts.

Nice to have

  • Batch release experience.
  • Experience with syringe and/or vial filling and inspection.

Culture & Benefits

  • Work on medicine and vaccine delivery in a regulated manufacturing environment.
  • Contribute to more than 30 new product launches planned by 2030.
  • Opportunities to develop new skills and explore cross-functional roles.
  • Eligibility to participate in company employee benefit programs.
  • Equal-opportunity workplace committed to inclusion and diversity.

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