Project Engineer – Life Sciences (Flanders)
ALTEN Belgium · Région flamande
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.
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Published 14 uur geleden
Expires over 1 maand
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ALTEN Belgium
Région flamande
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