Scientist/Engineer, Device Technical Operations (DDA) (18 Month Fixed Term Contract)

McDermott Laboratories Limited

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services.   

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Scientist/Engineer, Device Technical Operations (DDA) role will make an impact:

• Provide Design Assurance and Risk Management support for the transfer of manufacturing of Devices and Combination Products from the Global Device Development (GDD) Group in R&D to commercial manufacturing sites as per the GDD design control process in compliance with ISO 13485 and 21 CFR 820.

• Manage, review, and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/combination product.

• Provide Design Assurance and Risk Management support on site as required at suppliers or manufacturing sites for device-related complaints, support device-related investigations to root cause and the establishment of appropriate corrective actions.

• Review and Approval of Technical Operation Output Documentation

• Generate technical documentation to support medical device / combination product such as the following:

  • Risk Management Plan / Report

  • Benefit Risk Analyses

  • Medical Hazard List

  • General Safety and Performance Checklists

  • Notified Body Opinion Documentation

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Degree in Engineering/Science 

• Previous experience of Technical Transfer and/ or Technical Support in high volume GMP manufacturing environment for devices and/or combination products.

• Experience authoring technical reports and producing high quality documentation within a regulatory controlled GMP environment.

• A working knowledge of MDR 2017/745, ISO 14971, ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.

• It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams.

• The candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.

• Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.

• Willingness to travel as necessary between the Global Device Development Teams, Affiliates & suppliers.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris?

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.