Scientist, Device and Product Performance

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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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