Senior Scientist/Engineer, Device and Product Performance
Senior Scientist/Engineer, Device and Product PerformanceLocation: Northern Cross, Dublin, Ireland
Time Type: Full-Time
Posted On: 30 days ago
Job Requisition ID: R5649391
Company: McDermott Laboratories Limited
The Role & What You Will Be Doing As a Senior Scientist/Engineer on the Device and Product Performance (DPP) team, you'll be responsible for the testing of combination products within the Global Device Development (GDD) portfolio, which includes the generation of protocols, oversight of execution of testing at external test facilities, and the writing of reports. You'll also be involved in the execution of Design Verification activities within GDD programmes in support of design control activities while driving the strategic development of the DPP team process.
Every day, we rise to the challenge to make a difference and here's how the Senior Scientist/Engineer, Device and Product Performance role will make an impact:
Provide technical expertise to support the development of injectable combination products.Provide technical mentorship to more junior members of the injectables team, including guidance for technical issues and review/approval of documents.Lead the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites for programmes in the GDD portfolio in line with relevant guidelines and standards.Deal 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.Provide technical 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 and shipping studies.Trending and statistical analysis of analytical data including the compilation of technical reports to support combination product development lifecycle.Ensure that the combination product meets all requirements for reliability through the implementation of appropriate controls and assessment of the product against suitable specifications.Responsible for the compilation and review of technical documentation within GDD in line with global regulatory requirements, guidelines, and the latest regulatory and industry thinking.Lead and review device investigations and participate in GDD and technical investigation teams as required.About Your Skills & Experience Degree in Science/Engineering (Master's preferred).4+ years of experience in pharmaceutical and/or medical device development.Previous experience of working in R&D or Technical Services groups.Previous experience in managing activities with external test facilities, including test method development, validation, and transfer.Experience in the development and validation of analytical methods.Experienced in the application of statistical techniques for data analysis.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.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.
Benefits at Viatris Excellent career progression opportunitiesWork-life balance initiativesBonus schemeHealth insurancePensionDiversity & 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.
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.
#J-18808-Ljbffr