Senior Scientist/Engineer (Device and Product Performance)

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 Device Development is an innovative, technically-excellent and fully integrated organization, delivering access to high quality, safe, robust and effective device and combination products to meet the worlds’ evolving patient healthcare needs. 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.

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

Key responsibilities for this role include:

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

• Lead and provide technical support to a team responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.

• Provide technical mentorship to more junior members of the team, including guidance for technical issues and review/approval of documents.

• 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.

• Responsible for testing of combination products within the Global Device Development portfolio including generation of protocols, oversight of execution of testing at external test facilities and writing of reports.

• 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 all 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.

• Support equipment qualifications, vendor calibrations and preventative maintenance in line with the laboratory qualification and preventative maintenance schedule as required.

•  Lead general laboratory activities including; Procedure updates, generation of metrics, sample management, data review/ verification, instrument daily calibrations, shipping of samples.

• Delegation for the Lab manager as required.

Responsible for following all EHS process and procedures

The minimum qualifications for this role are:

• Degree in Science/Engineering (Master’s preferred)

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

• Experience in the development and validation of analytical methods

• Experienced in application of statistical techniques for data analysis.

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

• Experience of writing and supporting regulatory submissions would be an advantage

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

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

• Some travel will be required as part of this role.

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.

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.