Project Engineer Formulatie

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a Project Engineer Formulation you are responsible for coordinating validation and planning activities within capital projects, including the development, scheduling, and execution of project plans.
• You interpret and apply applicable GMP regulations (US and EU) and relevant international standards, including ISO and ICH.
• You coordinate verification and validation activities and prepare, review, and manage validation documentation in accordance with regulatory and quality requirements.
• You act as the primary point of contact for Engineering and Quality Assurance on validation-related topics and change control activities.
• You facilitate Quality Risk Assessments and provide subject matter expertise in verification, validation, and Quality Risk Management (QRM).
• You lead and manage one or more products or projects, including the resolution of urgent quality investigations and deviations.
• You perform risk assessments, drive change implementation, and support the introduction of new products into manufacturing or laboratory environments.
• You are responsible for the qualification and validation of method improvements within laboratory settings.
• You contribute to the development and validation of computer-controlled systems.
• You provide backup support to other project engineers as required.

Requirements

• Master’s degree in Civil, Industrial or Bio-Engineering, Industrial Pharmacy, or a related scientific discipline, or equivalent experience.
• Experience in a pharmaceutical production environment; exposure to aseptic processes, cleaning, disinfection, and sterilization is an asset.
• Strong communication and stakeholder management skills, with a well-organized and accurate working style.
• Excellent technical writing skills and attention to detail.
• Proficiency in both Dutch and English, written and spoken.

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.