Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?
- Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle
- Product/Process Qualification: Creation of protocols and reports for IQ, OQ, PQ, Test Method Validation (TMV) or Software Validation
- Collaboration with other departments (Manufacturing, Engineering, Inspection, logistics, etc.) to ensure proper execution of the validation and the tests
- Leading small projects in a timely manner
- Engineering degree or one in a related technical field (Bachelor or higher)
- At least 5 years of related experience in Quality Engineering / Validation
- Sound product validation experience
- Experience in reading product drawings
- Experience working in both an FDA and European regulatory environment is preferred
- Very good knowledge of product/process Risk Management (FDA and ISO standards)
- Good technical understanding of manufacturing equipment and processes
- Process Validation expertise is preferred
- Thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Demonstrated project management and project leadership abilities
- Business fluent in German and English
We are looking forward to getting to know you and your ambitions!