Process Engineer
2 weeks ago
Your Responsibilities
- Manage ETO projects in an international environment from definition to final approval
- Coordinate all activities for the project and create the final design and pricing
- Define specifications in cooperation with other departments like product development, quality, procurement, MSAT,sales and marketing for more complex projects
- Making technical and feasibility analyzes of projects
- Design new custom products using in-house design tool according to customer needs and internal design rules (Use of computer software design tool)
- Ensure product is manufacturable and define any qualification/testing that might be needed
- Calculate product cost and define price of the product in collaboration with marketing
- Coordinate all activities for industrialization of the product and order intake in an international and multi-sites environment
- Report project status
What will convince us
- Deep understanding of upstream (cell culture, fermentation) and downstream (purification, formulation) processes under GMP.
- Familiarity with GMP, FDA/EMA guidelines, batch documentation, method validation and ISO standards
- Using datadriven methods (DoE, FMEA) to diagnose bottlenecks, optimize designand ensure product quality.
- Active listening, needs assessment and tailoring technical solutions to meet customer requirements and timeline
- A first experience in project management in industry is a plus
- Fluent in English
- Excellent communication and coordination skills
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