R&D Engineer

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.

Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.

The Role & What You Will Be Doing

Execute Design Verification activities within GDD programs in support of design control activities. Drive strategic development of Device and Product Performance (DPP) team process.

Every day, we rise to the challenge to make a difference and here’s how the Scientist/Engineer, Device and Product Performance role will make an impact:

• Provision of technical expertise to support the development of Combination Products.

• Leading the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites.

• Dealing with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed such as manufacturing investigations.

• Trending and statistical analysis of analytical data including compilation of technical reports to support combination product development lifecycle.

• Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.

• Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking.

• Lead and review device investigations and participate in GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™.

• Support of R&D Lab activities including, Equipment calibration and Qualification, Documentation requirements, Trackwise records.

• Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.

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 Science/Engineering (Master’s preferred)

• 2+ years experience in pharmaceutical and/or medical device development

• Previous experience of working in R&D or Technical Services groups in the pharmaceutical or medical device industry

• Previous experience in the development and validation of analytical methods

• Experienced in application of statistical techniques for data analysis

• Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks

Desirable

• Previous experience working with pre-filled syringes, pen injectors or auto-injectors

• Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485

• Previous experience in technical writing to support regulatory communications, including submissions and information requests etc.

• Demonstrable success in the alignment of Device/Combination Product development programs with, at a minimum, the US FDA requirements for Combination Product / Medical Device (preferably also other territories)

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.

Benefits at 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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

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.