Senior Equipment &Method Validation Engineer
Novo Nordisk
- Hillerød, Hovedstaden
- Permanent
- Fuldtid
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Senior Equipment &Method Validation EngineerCategory: Engineering & TechnicalLocation:Hillerød, Capital Region of Denmark, DKAre you an experienced engineer with a strong background in equipment qualification and test method development? Are you ready to take charge of evolving and maintaining critical SOPs? We are looking for a Senior Equipment & Method Validation Engineer to join our team at Novo Nordisk in Hillerød, Denmark. If you are passionate about ensuring compliance, simplifying processes, and driving improvements, then read on and apply today for a life-changing career.The positionAs the Senior Equipment & Method Validation Engineer at Novo Nordisk, you will be the driving force behind the continuous improvement and stewardship of our essential standard operating procedures (SOPs) for test equipment validation and qualification. Your mission is to ensure our processes meet compliance standards, are streamlined for efficiency, and are regularly enhanced for optimal performance. You'll oversee the validated condition of our primary test equipment, shape new testing methods, and lead the overall validation efforts in our department. Your role extends to refining both internal and external workflows to ensure seamless operation without compromising on quality or compliance. This includes a proactive approach to evaluating and improving our SOPs, streamlining the document review process, and enhancing team collaboration. As a Senior engineer, you will mentor junior colleagues, exemplifying leadership, autonomy, and proactive initiative in your area of expertise. You will play a crucial role in our test equipment validation and qualification efforts.Your responsibilities will include:
- Identifying opportunities for improvement and driving initiatives to enhance processes and equipment.
- Serving as a subject matter expert in equipment qualification and test method validation.
- Developing and validating new test methods and establishing, qualifying, and maintaining test equipment.
- Ensuring compliant data management and adherence to stringent standards.
- Leading test method development and validation in device development projects.
- Exploring new technologies for future device testing and generating innovative ideas for test utilization.
- Hold a master's degree in engineering (e.g., materials, mechanical, biomedical) or a similar field within 5-8 years of work experience with in-depth knowledge of equipment qualification and test method development in the medical device industry.
- Demonstrate strong analytical skills and meticulous attention to detail.
- Have a background in medical device development. Possesses solid experience navigating medical device regulations.
- Have proficiency in essential documentation authorship and management.
- Possess knowledge of test standards, equipment, and/or method validations, as well as the ability to work in a GMP-regulated environment.
- Are familiar with design control processes pertaining to medical devices.