Principal Scientist/Engineer, Device and Product Performance

Position: Principal Scientist/Engineer, Device and Product Performance at Viatris Location: Discovery Park, Sandwich, Kent Role: Permanent Key responsibilities for this role include: Provision of subject matter expertise to support the development of Combination Products Leading a team to plan and execute design verification and reliability strategies. Responsible for technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development. Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements. Responsible for developing test methods and specifications to assess device functionality and product performance including evaluation, procurement & implement new, state-of-the-art lab testing equipment as applicable. Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification. Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans. Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliability. Ensures all activities within team are conducted and executed to the appropriate quality standards within the GDD Quality Management system. Lead support activities for external and internal audits and inspections as applicable. The minimum qualifications for this role are: Degree in Science/Engineering (Master’s preferred) Proven experience in pharmaceutical and/or medical device development Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage Experience in the development and validation of analytical methods Experienced in application of statistical techniques for data analysis Experience of writing and supporting regulatory submissions Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role. 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 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: Top Employer Accreditation, demonstrating that we provide excellent people policies and practices Focus on career progression with growth and development opportunities Emphasis on Health & Wellness programmes 100% paid medical insurance and Employee Assistance Programme Life cover Excellent employer-matched pension scheme with Viatris contributing up to 11%

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