Our client is the global number one manufacturer of choice for our partners who are looking for the highest quality and best service in the field of Orthobiologic Ceramics. We are working with the leading companies in the medical & dental (device) industries, start-ups with compelling business ideas and engaged universities. We co-op with our customers in the United States, Europe, Asia and in Emerging Markets. We will continue to seek and deploy technological and engineering advancements. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce. Due to growth in our company, we are looking for a Senior Process engineer
As a Senior Process Engineer within a fast-growing contract development and manufacturing organization you will be mainly responsible for developing new production processes and maintain and optimizing existing processes. The Senior process Engineer is responsible for the process development of divers’ products.
About the role
- Lead the development and implementation of manufacturing processes for complex product development projects.
- Manufacturing lead for the transfer of manufacturing for development projects including evaluation of processes to improve COGs and efficiency.
- Specify and source process equipment, packaging materials, and other equipment and materials to support manufacturing and product development for expansion and commercialization including automation.
- Technical lead for manufacturing for commercial production.
- Write and execute test protocols for trials of new materials, equipment, tooling, etc.in cooperation with operations and technical service functions
- Identify and develop process changes and modifications to enhance operating reliability and product quality and to improve efficiencies of key processes
- Plans, performs, and directs process validations, IQ, OQ, PQ and setting up process validation matrixes.
- Ensure all processes, changes, new processes and equipment has been reviewed and complies with current ISO and other quality and regulatory standards.
- Applying strong process design skills and knowledge to produce accurate and timely deliverables.
- Developing and preparing design documentation in written formats to meet project and client requirements.
Who are you?
- A Bachelor or Master’s degree in material sciences (Chemical technology or related) or comparable level through experience;
- At least 4-8 years relevant (international) experience within engineering preferably in a related field (medical devices, pharmacy);
- You are highly motivated, quality driven and a team player.
- Fluent English (verbal and written);
- Experience in an ISO13485 environment or equivalent (GMP)
- Comfortable making decisions within assigned authority, comfortable to escalate when needed.
If you think this sounds like your ideal new challenge, or if you have questions regarding this position we kindly ask you to contact ROBERT WHITE Staffing Solutions BV via email : email@example.com or call +31(6) 46 70 92 18 and ask for Robert de Wit