Validation Specialist

at  Viatris

Mylan Teoranta
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
The Validation Specialist will be responsible for supporting Validation activities including qualification and requalification of new and existing systems, equipment, utilities and facilities. This role will liaise with key departments and with third party suppliers, contract and vendor personnel as necessary to deliver the required objectives and in accordance with the overall Validation Master-Plan and Schedule.

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

• Responsible for planning, executing, reviewing & reporting validation activities supporting the qualification and requalification programs, Qualification will include Capex projects across a range of production areas including Cleanrooms, Facilities, Utilities, Production and Packaging equipment for a sterile manufacturing facility.
• Participate in project teams to assist in determining project schedules and be able to make risk-based decisions regarding the appropriate level of validation.
• Support in providing technical and compliance inputs to Validation and supporting documents ensuring compliance to cGMP.
• Responsible for input into the generation and documenting of process risk assessment / failure mode and effects analysis as required relating to introduction of new equipment supporting the Validation effort.
• Responsible for tracking and resolving exceptions during qualification activities.
• Represent validation at internal and external audit as requested.

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:

• Minimum of a Degree in a Science, Engineering or technical related discipline and 2+ years’ experience in a Technical/QA/ Validation Role within the pharmaceutical industry or a similar operating environment is preferable but not essential. A combination of experience and/or education will be taken into consideration.
• Experience and in-depth of Validation Processes, Equipment, Facilities and Utilities qualification will be a distinct advantage.
• Must possess knowledge of pharmaceutical and medical device regulatory requirements for FDA and HPRA regulated environments.
• Must possess knowledge of Pharmaceutical Manufacturing Programs
• In depth knowledge of steam sterilization processes, cleanroom qualification, process gases qualification and packaging equipment qualification is desirable.
• Must possess strong project management and organizational skills. Self-motivation and drive.
• Excellent interpersonal, communication (written & oral) & technical report writing skills.
• Must be flexible and able to manage multiple priorities simultaneously.
• Must be proficient in Microsoft Word, Excel, Powerpoint, Teams applications

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:

• Responsible for planning, executing, reviewing & reporting validation activities supporting the qualification and requalification programs, Qualification will include Capex projects across a range of production areas including Cleanrooms, Facilities, Utilities, Production and Packaging equipment for a sterile manufacturing facility.
• Participate in project teams to assist in determining project schedules and be able to make risk-based decisions regarding the appropriate level of validation.
• Support in providing technical and compliance inputs to Validation and supporting documents ensuring compliance to cGMP.
• Responsible for input into the generation and documenting of process risk assessment / failure mode and effects analysis as required relating to introduction of new equipment supporting the Validation effort.
• Responsible for tracking and resolving exceptions during qualification activities.
• Represent validation at internal and external audit as requested

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

• Minimum of a Degree in a Science, Engineering or technical related discipline and 2+ years’ experience in a Technical/QA/ Validation Role within the pharmaceutical industry or a similar operating environment is preferable but not essential. A combination of experience and/or education will be taken into consideration.
• Experience and in-depth of Validation Processes, Equipment, Facilities and Utilities qualification will be a distinct advantage.
• Must possess knowledge of pharmaceutical and medical device regulatory requirements for FDA and HPRA regulated environments.
• Must possess knowledge of Pharmaceutical Manufacturing Programs
• In depth knowledge of steam sterilization processes, cleanroom qualification, process gases qualification and packaging equipment qualification is desirable.
• Must possess strong project management and organizational skills. Self-motivation and drive.
• Excellent interpersonal, communication (written & oral) & technical report writing skills.
• Must be flexible and able to manage multiple priorities simultaneously.
• Must be proficient in Microsoft Word, Excel, Powerpoint, Teams application