Associate Scientist, Device and Product Performance
Associate Scientist, Device and Product Performance
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Job Description
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 heres how the Associate Scientist Devices and Product Performance role will make an impact:
Key responsibilities for this role include:
Support of all R&D Lab activities including Equipment calibration and Qualification Documentation requirements Trackwise records.
Execute Incoming Inspection on components and/or sub-assemblies in line with site procedures and in a timely manner to support device development activities.
Support the 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.
Support the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites.
Proactively contribute through ownership of the deliverables of the quality objectives defined within the GDD QMS.
General laboratory activities including Procedure updates generation of metrics sample management data review/ verification instrument daily calibrations shipping of samples.
Trending and statistical analysis of analytical data including compilation of technical reports to support combination product development lifecycle.
Lead and review device investigations and participate in GDD and technical investigation teams as . Reporting and logging of aberrant results using Trackwise.
Adhere to ISO 13485 in line with the Global Device Development QMS ensuring audit readiness at all times.
Support equipment qualifications vendor calibrations and preventative maintenance in line with the laboratory qualification and preventative maintenance schedule.
Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.
The minimum qualifications for this role are:
Masters/Degree in Engineering/Science with proven post graduate experience
Previous experience using in a regulated GMP environment would be an advantage.
Working proficiency with Minitab would be an advantage.
Well-developed communication skills to lead or facilitate effective discussions.
Meticulous attention to detail with an analytical approach to problem solving.
Some travel may be 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 offercompetitivesalaries benefitsandan 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.
Required Experience:
IC
Employment Type
Full-Time
