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19 часов назад

Manager Quality Engineering – Lab and Computerized System Validation

79 800 - 137 770
Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
c1
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
Manager Quality Engineering – Lab and Computerized System Validation (GMP/CSV): Leading quality management and governance for laboratory, manufacturing automation, and IT systems used in API and drug product intermediate manufacturing with an accent on qualification, computerized system validation, compliance, and continuous improvement. Focus on reviewing validation documentation, managing system changes and deviations, preparing for inspections, and coaching the QA Qualification/CSV team.

Location: Geel, Antwerp, Belgium; full-time onsite role

Salary: €79,800–€137,770 annual base pay

Company

Johnson & Johnson MedTech develops healthcare and innovative medicine solutions, including APIs and drug product intermediates manufactured at the Geel site.

What you will do

  • Lead and coach the QA Qualification and Computerized System Validation team while managing resources, budget, and key performance indicators.
  • Ensure qualification and CSV compliance throughout the lifecycle of laboratory, manufacturing automation, and IT systems.
  • Review and approve validation documentation, system quality reviews, validation master plans, trend reports, calibration records, and maintenance records.
  • Support system introductions and change projects, ensuring quality and compliance requirements are met.
  • Prepare for regulatory and customer inspections and represent QA Qualification/CSV topics during audits.
  • Investigate system-related deviations and implement corrective and preventive actions while continuously improving qualification and CSV processes.

Requirements

  • Master’s degree in a scientific field or equivalent experience.
  • 5–10 years of experience in chemical or pharmaceutical supply chain and/or quality.
  • Fluent Dutch and English, written and spoken.
  • Thorough knowledge of cGMP regulations and qualification/CSV guidelines.
  • Knowledge of laboratory, IT, and automation systems used in manufacturing.
  • Strong analytical, risk assessment, communication, managerial, leadership, collaboration, and continuous improvement skills.

Culture & Benefits

  • Work in a technology-focused QA team supporting a biomedicine manufacturing operation.
  • On-the-job training, e-learning, projects, and programs supporting professional development.
  • Indefinite-duration employment contract with an attractive benefits package.
  • Benefits include meal vouchers, an additional pension plan, hospitalization insurance, vacation and parental leave, well-being reimbursement, and health and financial support programs.
  • Annual bonus, recognition awards, and opportunities for challenging projects and further education.

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