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Scientist, Device and Product Performance
Solicitar locations Northern Cross, Dublin, Ireland time type Tiempo completo posted on Publicado hace 5 días job requisition id R5660477 McDermott Laboratories Limited
En VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.
Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.
Lo hacemos a través de:
Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;
Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;
Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.
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 ris e to the challenge to make a difference and here’s how the Scientist /Engineer ( Device and Product Pe r formance ), will make an impact :
Key responsibilities for this role include:
* Provision of technical expertise to support the development of Combination Products.
* R esponsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.
* Performing D evelopment 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.
* 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 g eneral laboratory activities including; Procedure updates, generation of metrics, sample management, data review/ verification, instrument daily calibrations, shipping of samples.
Responsible for following all EHS process and procedures
The minimum qualifications for this role are:
* Degree in Science /E ngineering (Master’s preferred)
* Proven 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 salar ies, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.
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