Senior Equipment &Method Validation Engineer

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Hillerød

Are 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 [xxxxx] 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 position As the Senior Equipment & Method Validation Engineer at [xxxxx], 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.
    • Qualifications To succeed in this role, we expect that you:
  • 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.
    • As a person, you possess excellent coordination and communication skills, allowing you to effectively interact with colleagues and stakeholders. Your strong problem-solving and analytical skills enable you to tackle complex issues with precision and efficiency. You exhibit the ability to work both independently and collaboratively within a team, adapting seamlessly to various working environments and contributing to collective goals with dedication and expertise. About the department The Senior Method Validation Engineer position is located at site Hillerød in Denmark. Our department is known for its independence, innovation, and proactive initiatives. We work independently to achieve targets agreed upon in Packaging and Verification Development (PVD). We are constantly seeking new process initiatives for development projects and new technologies. We also actively collaborate with external partners to stay competitive and up to date with the latest advancements in our field. We explore and develop scalable and sustainable packaging and delivery solutions. We verify and validate that delivery solutions meet requirements and fulfil the needs of the drug and users. By establishing and qualifying state of the art analytical equipment and test methods in our labs, we plan and execute tests to demonstrate that containers, packaging, and delivery solutions perform as intended. Working at [xxxxx] [xxxxx] is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at [xxxxx] is working toward something bigger than ourselves, and it’s a collective effort. [xxxxx] relies on the joint potential and collaboration of its more than 60,000 employees. Together, we go further. Together, we’re life-changing. Contact For further information, please contact Filippo Cavalca, Team Leader Equipment, CT & Methods at +[xxxxx] Deadline 31 May 2024. Interviews will be held throughout the posting period; so, we encourage you to send your application as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 10.5.2024, men kan have været deaktiveret og genaktiveret igen.

    Rapportér
    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 10.05.2024
    • Øvrige
    • Hillerød
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