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3 дня назад

Process Assessment and Validation Scientist II (CGT)

48 000 - 67 200€
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Netherlands
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 Assessment and Validation Scientist II (CGT): Executing process assessment, validation, and post-Technology Transfer support for CGT manufacturing processes in a GMP environment with an accent on aseptic processing, Aseptic Process Simulation, and risk mitigation. Focus on evaluating process, facility, equipment, and material risks, leading root-cause investigations, and driving continuous process improvement.

Location: Geleen, Netherlands; minimum 4 days on site

Annual base pay: EUR 48,000–67,200

Company

hirify.global operates globally connected sites focused on manufacturing medicines and turning customers’ life-science innovations into viable therapies.

What you will do

  • Execute process assessment and validation activities with internal and external partners, delivering against agreed project timelines.
  • Evaluate process design, Aseptic Process Simulation, facility layout, equipment, and materials from a GMP perspective.
  • Identify process-related risks and define effective mitigation strategies.
  • Monitor and trend performance data during and after Technology Transfer, assess process capability, and drive continuous improvement.
  • Lead root-cause investigations and technical troubleshooting for process-impacting deviations as a Subject Matter Expert.
  • Champion Operational Excellence and continuous improvement across process activities.

Requirements

  • Deep understanding of CGT manufacturing technologies, process assessment, and advances in the field.
  • Practical expertise in Good Manufacturing Practice standards, aseptic processing, and Aseptic Process Simulation.
  • Proven ability to evaluate process, facility, equipment, and material risks and implement robust mitigation plans.
  • Experience building strong working relationships with clients and cross-functional internal teams.
  • Exceptional written and verbal communication skills, with a commitment to transparency and clarity.

Culture & Benefits

  • Agile and dynamic working culture.
  • Inclusive and ethical workplace committed to diversity.
  • Compensation programs recognizing high performance.
  • Benefits vary by role and location.
  • Values include Collaboration, Accountability, Excellence, Passion, and Integrity.

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