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.

Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. 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.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Device Product Performance, Senior Lab Equipment and System Engineer role will make an impact:

Manage all Equipment Installation and Qualification, Computer System Validation (CSV), Preventative Maintenance and Calibration Schedules and ensuring compliance with GDD’s Quality Management System.

Develop and update documentation relating to equipment use and qualification, in line with Regulatory standards.

Keeping up to date on administrative responsibilities such as maintaining QC test service logs and service records in a timely manner.ç

Basic troubleshooting, maintenance and repair on QC test equipment and ensure all Data Integrity requirements are met for all lab systems.

Maintaining daily communications with QC team to ensure resolution and proper follow-up.

Maintaining tools and test equipment and ensuring they are properly calibrated.

Utilizing the escalation process to resolve delivery issues.

Identifying and participating in product transfers for new test systems and provide relevant training of the test equipment as required.

Adhering to current regulatory requirement such as (but not limited to) ISO 13485, FDA.

Support the closure of QMS activities in conjunction with DDA.

Accountable for ensuring operations are fully compliant with EH&S legislation, and corporate requirements and guidelines. Actively promote a positive and engaged EH&SS culture. Self-motivated, results oriented with strong planning and scheduling skills.

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 Science and/or Engineering with at least 4 years’ experience in a GMP or ISO 13485 accredited laboratory

The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment

Experience of supporting laboratory readiness for inspections and participating in an FDA or HPRA audit 

Experience of leading and approving laboratory equipment qualification including Computer System Validation

Strong Technical writing skills

A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.

An understanding of the requirement to meet project and team orientated goals and the ability to create win-win relationships with other functions to meet these goals

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. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.

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.

Benefits at 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. Some of our benefits include the following on top of a competitive salary:

Excellent career progression opportunities

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion

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 visit https://www.viatris.com/en/about-us/corporate-responsibility

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. 

Viatris is an Equal Opportunity Employer.