Scientist/Engineer, Device Technical Operations (Design) (18 Month Fixed Term Contract) page is loaded## Scientist/Engineer, Device Technical Operations (Design) (18 Month Fixed Term Contract)locations: Northern Cross, Dublin, Irelandtime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: R*******McDermott Laboratories LimitedBei VIATRIS, sehen wir das Gesundheitswesen nicht so, wie es ist, sondern so, wie es sein sollte.
Wir handeln entschlossen, und unsere einzigartige Positionierung sorgt für Stabilität in einer Welt, in der sich die Bedarfe im Gesundheitswesen stets verändern.
Viatris befähigt Menschen in allen Teilen der Welt, in jeder Lebensphase gesünder zu leben.
Dies erreichen wir durch:*Zugang* – Zugang zu hochwertigen, bewährten Arzneimitteln und Impfstoffen sowie auch neu entwickelten Biosimilars für Patienten in allen Lebensumständen weltweit*Führungsverantwortung* – Verbesserung der Patientengesundheit durch zukunftsgerichtete nachhaltige Unternehmensführung und innovative Lösungen*Partnerschaft* – Optimaler Einsatz unserer Kompetenzen, um Menschen den Zugang zu Produkten und Dienstleistungen zu ermöglichen.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 (Design)** 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 ***** 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.
* 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: + User Needs & Requirements + User FMEA + Design Requirements + Design FMEA + Packaging and Labelling Requirements + Process FMEA and Manufacturing support at site + Design Validation Strategy**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 ********, ISO ***** & 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 visitBei Viatris, bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein integratives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten einsetzen können, um das Leben anderer zu beeinflussen.
### Ähnliche Stellen (1)locations: Northern Cross, Dublin, Irelandtime type: Vollzeitposted on: Heute ausgeschrieben
#J-*****-Ljbffr