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9 дней назад

Process Engineer (Medior Level / 3-8 Years Experience) (Sterile Manufacturing)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
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
Process Engineer (Medior Level / 3-8 Years Experience) (Sterile Manufacturing): Supporting sterile manufacturing projects as a technical user representative, with an accent on GMP compliance, aseptic processing, troubleshooting, and digital and engineering project implementation. Focus on defining user requirements, coordinating qualification and validation activities, managing deviations and change controls, and training end users through implementation and first batches.

Location: Onsite at a client site in Brussels, Belgium

Company

hirify.global delivers engineering and project support services for industrial and sterile manufacturing environments.

What you will do

  • Support sterile manufacturing projects aligned with departmental strategy and roadmap, delivering activities within scope and on time.
  • Provide technical support for production troubleshooting, equipment investigations, digitized processes, and related engineering activities.
  • Draft, review, and approve cGMP documentation, including procedures, protocols, reports, and operational records.
  • Define user requirements, coordinate project activities, follow development and implementation, and support qualification and validation testing.
  • Manage deviations, investigations, change controls, and associated CAPA; lead or support technical investigations.
  • Act as a point of contact, trainer, and coach for end users, including field follow-up during implementation and first batches.

Requirements

  • 3-8 years of experience at medior level, with theoretical and strong practical project management expertise.
  • Master’s degree in bio-engineering, process engineering, mechanical engineering, chemical engineering, industrial pharmacy, chemistry, or biology, or proven equivalent experience.
  • Strong safety mindset and knowledge of industry safety standards.
  • Good knowledge of GMP requirements for sterile product development and manufacturing.
  • Strong knowledge of aseptic manufacturing practices, bulk filling, and aseptic filling.
  • Knowledge of visual inspection processes; manual and semi-automatic experience is required, while fully automatic inspection is a plus.
  • Very good interpersonal communication skills, with the ability to collaborate with internal customers and support departments.
  • Autonomous, rigorous, proactive, organized, and able to prioritize multitasking activities while meeting deadlines.
  • Ability to work in a highly matrixed and dynamic environment, solve problems innovatively and practically, and contribute effectively as part of a team.

Culture & Benefits

  • Onsite project work in a sterile manufacturing environment.
  • Work in accordance with GMP requirements and maintain permanent inspection readiness.
  • Collaboration with sterile manufacturing, production, internal customers, and support departments.
  • Contract position supporting digital and non-digital engineering projects.

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