Validation Specialist for Medical Device Development
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Hillerød
Are you passionate about making a difference in the lives of patients? Do you want to set the direction for our equipment and test method validation in device and primary packaging testing and verification?If you are well-versed in design verification, compliance, and improving processes to enhance efficiency and ensure adequate compliance levels, you could be our new Validation Specialist.
The positionAs a Validation Specialist, you will play a versatile role, collaborating with multiple stakeholders including line management, QA, process experts, test and validation engineers, and commercial device manufacturing. You will be instrumental in steering our Science and Risk-Based Validation (SRV) approach for medical device and delivery solution development testing, as well as participating in internal SRV process groups and process manager groups within Final Product Development (FP Dev), part of Product Supply (PS).
Your main responsibilities will be focused on:Setting direction and making strategic decisions for our validation processes Interpreting requirements in conjunction with our QA colleagues, ensuring compliance with relevant quality systems Continuously simplifying and optimizing processes to ensure robust and scalable test methods from development to finished goods production Actively driving and participating in deviations and Systematic Problem-Solving activities You will also have the opportunity to train, guide, and support colleagues, working closely with engineers and specialists in verification, method validation, dosing, and equipment to ensure high-quality and timely test equipment and test methods for device and delivery solution development projects.QualificationsTo be a great candidate, you should have:A degree in engineering, natural science, or a related field, or a relevant background in the medical device industry with experience in medical device regulations and compliance A minimum of 8 years of experience in qualification equipment and process validation Experience in QC equipment and method validation is also highly relevant and appreciated Familiarity with SRV principles is a minimum requirement, along with significant experience in optimizing working processes Structured mind, being a natural collaborator, and a solid communicator with a strong drive for simplifying qualification and validation processes. You possess the ability to navigate complexity within compliance frameworks and empower colleagues through capability building Supportive mindset and leadership skills team to establish direction within Science and Risk-Based Validation
About the department
You will join the Equipment & CT team, part of the Testing & Verification department in Final Product Development (FPDev). Our team, consisting of passionate colleagues, plays an important role in the medical device and primary packaging development process. We deliver specialized exploratory testing and design verification. Our responsibility includes specifying, developing, purchasing, and validating new test equipment to support and conduct verification testing of medical devices.
In our team, we greatly value collaboration and support. We actively encourage each other to share knowledge and tackle challenges together, which not only fosters professional growth but also makes the work environment enjoyable and rewarding. Together, we solve exciting tasks while enjoying a friendly and inclusive atmosphere.
ContactFor further information, please contact Manager Filippo Cavalca at
Deadline
10 August 2025
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in yourresume 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 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.
The positionAs a Validation Specialist, you will play a versatile role, collaborating with multiple stakeholders including line management, QA, process experts, test and validation engineers, and commercial device manufacturing. You will be instrumental in steering our Science and Risk-Based Validation (SRV) approach for medical device and delivery solution development testing, as well as participating in internal SRV process groups and process manager groups within Final Product Development (FP Dev), part of Product Supply (PS).
Your main responsibilities will be focused on:
About the department
You will join the Equipment & CT team, part of the Testing & Verification department in Final Product Development (FPDev). Our team, consisting of passionate colleagues, plays an important role in the medical device and primary packaging development process. We deliver specialized exploratory testing and design verification. Our responsibility includes specifying, developing, purchasing, and validating new test equipment to support and conduct verification testing of medical devices.
In our team, we greatly value collaboration and support. We actively encourage each other to share knowledge and tackle challenges together, which not only fosters professional growth but also makes the work environment enjoyable and rewarding. Together, we solve exciting tasks while enjoying a friendly and inclusive atmosphere.
ContactFor further information, please contact Manager Filippo Cavalca at
Deadline
10 August 2025
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in yourresume 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 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.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 14.4.2025, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Projektleder
- Hillerød
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