Project Engineer STS ( PE Single Use)

As a Project Engineer (PE) STS P roduct & Process materials you are responsible for product and  process materials and filters.  

You are responsible for a broad spectrum of tasks, including determining single-use systems and materials in function of the product and process , urgent quality investigations , risk assessments , validating / implementing changes and compliance documentation according to the latest guidelines .  

You will develop expertise in a specific domain of product and process materials and filters . You work intensively with internal departments such as Production, QA, Procurement and Supply , Pfizer external departments (R&D, center functions) and with external suppliers of the relevant materials to guarantee quality and supply , so communication is essential . 

• You coordinate the entire process, both for new process materials and filters and for improving existing ones, generating or evaluating new ideas, conducting feasibility studies and risk assessments, conducting tests and final implementation in production.  

• You determine the Critical Quality Attributes (quality requirements) of the materials based on process knowledge (both processing in local processes and production processes at suppliers) , authority requirements , with a view to product quality and patient safety . You translate these requirements into technical and qualifying requirements  

• You validate and document everything correctly and accurately . 

• You profile yourself as a specialist in this area by continuously staying informed of production issues and feedback from the market. You analyze this information and use the necessary tools to realize improvements and you take overarching actions. 

• You work closely with suppliers/production to implement the right actions in case of problems.  

• You ensure that work is always done in compliance with the applicable regulations   

Job profile

• Master's degree: Bio-Engineer, Industrial Pharmacist, Civil or Industrial Engineer, master or PhD in a scientific field. 
• Enthusiastic team player.  
• Dynamic, enthusiastic and continuously eager to learn. 
• Respect for agreed decisions and procedures as well as discipline in carrying out projects. 
• Good communication skills including persuasion and compromise. 
• Good documentation skills 
• You work organized and accurately 
• Good analytical skills. 
• Perfect command of Dutch and English 
• research methodologies for root cause research for trouble shooting 
• GMP environment and knowledge of quality systems (cGMP) 

Offer:

• Indefinite contract with numerous fringe benefits
• A culture of entrepreneurship and innovation
• Largest production and packaging site in Europe within the Pfizer network
• High investment rhythm
• High-tech environment

  
Work Location Assignment: Flexible