ScientistEngineer, Device Technical Operations (DDA) (18 Month Fixed Term Contract)
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Job Location:
Monthly Salary:
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
At VIATRIS we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access Providing high quality trusted medicines regardless of geography or circumstance;
Leadership Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership Leveraging our collective expertise to connect people to products and services.
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 heres how the Scientist/Engineer Device Technical Operations (DDA)role will make an impact:
Provide Design Assurance and Risk Management 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.
Manage review and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/combination product.
Provide Design Assurance and Risk Management support 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.
Review and Approval of Technical Operation Output Documentation
Generate technical documentation to support medical device / combination product such as the following:
Risk Management Plan / Report
Benefit Risk Analyses
Medical Hazard List
General Safety and Performance Checklists
Notified Body Opinion Documentation
About Your Skills & Experience
For this role were 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 14971 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 youre excited about this role but your past experience doesnt fully align with every requirement we still encourage you to apply. You may just be the right candidate for this or other roles.
Why 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. 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 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 visit Viatris we offercompetitivesalaries benefitsandan inclusive environment where you can use your experiences perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
Required Experience:
IC
Key Skills
- IVR
- SOAP
- Avaya
- Solaris
- Cost Accounting Standards
- Database Design
- Hibernate
- ITIL
- Weblogic
- Express.js
- Contracts
- ASP
About Company
Viatris is a global pharmaceutical company that believes in healthcare not as it is, but as it should be. Learn about our story, explore our products and browse career opportunities.
