Successfully introducing new medicines to a production site requires extensive preparation behind the scenes. Processes must be validated, risks correctly assessed, changes implemented, and everything must, of course, comply with applicable quality and regulatory requirements. For a leading international pharmaceutical player, we are looking for Project Engineers who will contribute to the introduction of new products on the site within Launch Excellence.
As a Project Engineer, you will be responsible for the validation aspects associated with these product introductions and combine content follow-up with project coordination.
What you will do.
- You validate and document processes within formulation, filling, shipping
- You conduct urgent quality investigations and ensure correct documentation and follow-up
- You prepare risk assessments and determine appropriate mitigating measures
- You support and implement process and system changes required for new product introductions
- You take care of general project follow-up: coordination, planning, issue resolution, and progress reporting
- You monitor that new products are successfully implemented in accordance with applicable GMP and quality requirements
- You work closely with various teams and stakeholders within the organization
What they are looking for.
- You have a Master's degree in a scientific field, such as Bio-engineering, Pharmacy, Biochemistry, Biotechnology, or a comparable education
- You work in an organized, accurate, and quality-conscious manner
- You possess strong analytical and problem-solving skills
- You are a strong communicator and enjoy collaborating with various stakeholders
- You can work independently as well as take responsibility within a team
- You are pragmatic, proactive
- You have a good technical writing style
- You speak and write excellent Dutch and have a good knowledge of English
- Experience with validation projects, planning, and project coordination is a clear added value
- Experience within a GMP environment and knowledge of risk assessment and validation processes are important
- Flexibility for shift work may be required for certain projects
Practical
You will be employed as a Science Consultant with an indefinite contract and start on a long-term project at a client's site. These projects typically last 1 to 3 years. After one year, there is also the possibility, if you wish, to transfer to a permanent contract with the client.
How to apply
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