Life Sciences Validation & Compliance Project Engineer

Capgemini Engineering

Diegem

Hybride

EUR 60 000 - 80 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Hybrid work

Mentoring programs

Learning platforms access

Résumé du poste

Capgemini Engineering in Belgium is seeking a Medior Project Engineer – Validation & Compliance to coordinate validation activities within regulated pharmaceutical projects. You will liaise between Engineering and Quality Assurance to ensure safe, compliant, and efficient delivery across capital projects.

The role emphasizes GMP and ISO/ICH standards, technical writing, and ensuring traceability from planning through implementation.

Qualifications

Master's degree in Engineering or related scientific field; equivalent experience considered.
Minimum of 2 years in a regulated pharmaceutical or production environment with GMP understanding.
Strong communication and stakeholder management across cross-functional teams.
Fluent in Dutch and English with excellent technical writing and attention to detail.
Experience with aseptic processes, cleaning, disinfection, sterilisation, or lab environments is advantageous.

Responsabilités

Coordinate validation and verification activities across capital projects, monitoring schedules from planning to implementation.
Interpret and apply GMP regulations (US and EU), ISO, ICH, and internal quality standards as liaison between Engineering and QA.
Draft, review, and manage validation protocols and qualification documents with precise technical writing.
Lead Quality Risk Assessments and support investigations related to quality issues and change control.
Manage multiple projects, contribute to continuous improvement, support new product introductions.
Assist qualification and validation of analytical methods and support computer-controlled systems when applicable.