Validation Specialist

at  Viatris

Rottapharm Limited
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 here’s how the Validation Specialist role will make an impact:

• Process Validation/Qualification projects will be across a range of production areas which may include Process, Cleaning, Software, Utility and Facility projects.
• Generation, execution and close out of validation projects relating to existing products and new product introductions.
• Responsible for the ongoing process validation programme: drafting OPV protocol, report and assess the process stability and capability.
• Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).
• Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
• Execution and documenting risk assessments (FMEA) with respect to validation activities.
• Perform validation functional testing as required. Track and resolve deviations during qualification activities.

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:

• Bachelor’s degree in Science, Engineering, Technology or a related discipline.
• 2 years of hands-on experience working as a validation engineer/specialist in a cGMP environment, preferably in an oral solid dose facility.
• Experience in using Minitab.
• Full understanding of cGMP requirements, including Annex 11 and Annex 15.
• Effective technical writing skills.
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills.
• Flexible and able to manage multiple priorities simultaneously.

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.

Every day, we rise to the challenge to make a difference and here’s how the Validation Specialist role will make an impact:

• Process Validation/Qualification projects will be across a range of production areas which may include Process, Cleaning, Software, Utility and Facility projects.
• Generation, execution and close out of validation projects relating to existing products and new product introductions.
• Responsible for the ongoing process validation programme: drafting OPV protocol, report and assess the process stability and capability.
• Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).
• Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
• Execution and documenting risk assessments (FMEA) with respect to validation activities.
• Perform validation functional testing as required. Track and resolve deviations during qualification activities

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s degree in Science, Engineering, Technology or a related discipline.
• 2 years of hands-on experience working as a validation engineer/specialist in a cGMP environment, preferably in an oral solid dose facility.
• Experience in using Minitab.
• Full understanding of cGMP requirements, including Annex 11 and Annex 15.
• Effective technical writing skills.
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills.
• Flexible and able to manage multiple priorities simultaneously