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
Work Location Assignment: Flexible
The Pfizer site in Puurs is one of Pfizer's largest production and packaging sites worldwide, specialized in aseptic production and packaging. More than 400 million doses of injectable vaccines and medicines are produced in Puurs every year. These are packaged on site in ampoules, vials, plastic bottles, syringes and pen cartridges.
The medicines made in Puurs are intended for patients in more than 170 countries worldwide. 30% of the production from Puurs is intended for developing countries, in collaboration with UNICEF, WHO, GAVI and NGOs.
By using two wind turbines, solar panels and a cogeneration plant, we focus on renewable energy.