Job Description
Device and Product Performance Scientist (12 month Fixed Term Contract)Location: Northern Cross, Dublin, IrelandTime Type: Full TimePosted On: Offer published yesterdayAbout UsAt Viatris, we envision health not just as it is, but as it should be. We act with courage, and our unique positioning provides stability in a world where health needs are constantly evolving. We enable everyone worldwide to live healthier at every stage of life.The Role & What You Will Be DoingLead the development of combination Product methods in the R&D Laboratory while providing technical mentorship to junior team members, including guidance for technical issues and review/approval of documents as well as support for the lab manager.Every day, we rise to the challenge to make a difference and here’s how the Device and Product Performance Scientist role will make an impact:Provision of technical laboratory expertise to support the development of Combination Products.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 junior team members, 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 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 and guidance.Lead and review device investigations and participate in GDD and technical investigation teams as required.Support 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.About Your Skills & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:Experience in the development and validation of analytical methods.Experienced in application of statistical techniques for data analysis.Masters/Degree in Engineering/Science with minimum 2 years’ experience in a lab environment.Previous experience in a regulated GMP environment.Working proficiency with Minitab.Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks.Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485.Well-developed communication skills to lead or facilitate effective discussions.Some travel may be required as part of this role.Benefits at ViatrisAt 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:Excellent career progression opportunities.Work-life balance initiatives.Bonus scheme.Health insurance.Pension.Diversity & Inclusion at ViatrisAt 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.Sustainability at ViatrisCorporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations. #J-18808-Ljbffr