Scientist/Engineer, Device Technical Operations (Analytical) (18 Month Fixed Term Contract)jobtraffic • Ireland
Scientist/Engineer, Device Technical Operations (Analytical) (18 Month Fixed Term Contract)
jobtraffic
- Ireland
- Ireland
About
Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.
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;Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.
We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience.
Viatris is more than just a place to work.
This is a place to make a difference in the world.
**The Role & What You Will Be Doing
**Every day, we rise to the challenge to make a difference and here’s how the
**Scientist/Engineer, Device Technical Operations (Analytical)
** role will make an impact:
* Provide technical support for the transfer of manufacturing of Devices and Combination Products from the Global Device Development (GDD) Group in R&D to commercial manufacturing sites as per the GDD design control process in compliance with ISO 13485 and 21 CFR 820.
* Act as the interface between R&D and the commercial manufacturing sites during device/combination product development and provide support for the troubleshooting of all device related issues/investigations.
* Manage, review, and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/combination product.
* Develop manufacturing process understanding by use of tools such as Cause and Effect, providing linkage to all aspects of manufacturing and utilized to identify any potential failures.
* Provide technical support and act as technical SME on site as required at suppliers or manufacturing sites for device-related complaints, support device-related investigations to root cause and the establishment of appropriate corrective actions.
* Generate technical documentation to support medical device / combination product such as the following: + Device Requirements + Test Methods + Product / Purchasing Specifications + Design Verification Strategy / Protocols & Reports + Laboratory Investigation Support
**About Your Skills & Experience
**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
* Degree in Engineering/Science
* Previous experience of Technical Transfer and/ or Technical Support in high volume GMP manufacturing environment for devices and/or combination products.
* Experience authoring technical reports and producing high quality documentation within a regulatory controlled GMP environment.
* A working knowledge of MDR 2017/745, ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
* It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams.
* The candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
* Well-developed communication skills to lead or facilitate effective discussions.
Able to communicate technical and/or project information to key stakeholders.
* Willingness to travel as necessary between the Global Device Development Teams, Affiliates & suppliers.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.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.
You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
**Diversity & 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.
If you would like to know more about what diversity, equity and inclusion means to us, please visit
**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, recognizing that our actions affect the stakeholders and communities we serve.
To learn more about our efforts, please visitEn 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.Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer.
Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox.
45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias.
Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. xcfaprz
Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten.
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Languages
- English
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