For a Nijmegen based Pharmaceutical & Medical Device company a Project Engineer is needed to manage various Internal & External Projects.
As a Project Engineer within the Projects, Engineering & Maintenance department you are responsible for working in and managing various projects. These are both internal projects in the field of equipment and installations as customer projects. In addition, you are involved in performing qualification and process validation projects of existing equipment and newly developed products / processes.
- Efficient execution of technical projects with regard to equipment, installations and / or cleanrooms (including drawing up URS, qualification documents and providing training).
- Collaborate with external partners and suppliers to ensure that their products and services meet the quality standards.
- Execute and check FAT / SAT and DQ / IQ / OQ / PQ trajectories (equipment qualification).
- Guiding process validations to meet relevant requirements.
- Preparing process validation programs and validation documents for new and existing products/processes.
- Assessing the need for process re-validation using FMEAs, SPC and process evaluations.
- Project management; drawing up a project plan, project planning, progress documents and monitoring and focus on progress, quality and budget.
- Regular contact with customers through calls, progress meetings and email.
- Masters in relevant or experience in a technical field such as Process, (Bio) Chemical or Medical Technology.
- Minimum 3 years of relevant working experience
- Experience and knowledge in Project Management
- Experience with equipment qualification and process validation.
- Previous experience in Medical Devices & Pharmaceuticals production environment.
- You speak / write fluent Dutch & English (German & French advantageous).
- Good knowledge of Microsoft package.
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