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Project Engineer – Life Sciences (Flanders)

ALTEN Belgium · Région flamande

New
CDI 🇬🇧 English
GMP regulations qualification documentation Quality Risk Assessment computer-controlled systems

Job description

About the role

ALTEN Belgium is seeking a Project Engineer to support validation and verification activities on capital and improvement projects within the life‑sciences sector in Flanders. You will act as a bridge between Engineering and Quality Assurance, ensuring compliance with GMP, ISO and ICH standards.

Key responsibilities

  • Coordinate validation and verification tasks for capital and improvement projects.
  • Plan, schedule and manage project activities according to defined procedures and timelines.
  • Interpret and apply GMP regulations (EU/US) and international standards (ISO, ICH).
  • Draft, review and maintain validation and qualification documentation.
  • Serve as the primary contact for validation and change‑control topics between Engineering and QA.
  • Facilitate Quality Risk Assessments (QRM) and support risk‑based investigations.
  • Manage qualification and validation of method improvements in laboratory environments and support computer‑controlled system development.

Required profile

  • Master’s degree in industrial, civil, bio‑engineering, industrial pharmacy, biotechnology, biochemistry, pharmacy or equivalent experience.
  • Experience in production environments, preferably in pharmaceutical or life‑sciences industry.
  • Knowledge of aseptic processes, cleaning, disinfection and sterilisation is an asset.
  • Strong communication, stakeholder management and technical writing skills.
  • High accuracy, attention to detail and fluency in Dutch and English.

Required skills

  • GMP regulations (EU/US)
  • ISO standards
  • ICH guidelines
  • Validation and qualification documentation
  • Quality Risk Assessment (QRM)
  • Computer‑controlled system support

What we offer

  • Permanent contract with a competitive salary package.
  • Additional benefits such as company car, meal vouchers, recovery days and insurances.
  • Opportunities to join a large international network and grow within ALTEN’s Academy.
  • Possibility to work as a freelancer.

Questions fréquentes

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Le contrat proposé est un CDI basé à Région flamande.

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Published 14 uur geleden

Expires over 1 maand

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ALTEN Belgium

Région flamande