Mylan TeorantaAt 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; andPartnership – 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 DoingThe Senior Validation Specialist will take the lead and project manage validation/qualifications activities at Mylan Institutional.
The Senior Validation Specialist assumes responsibility for overseeing and where required execution of Validation/Qualification activities.
This will require the individual to liaise with Engineering, Operational, QA/QC, Microbiology, EHS, and regulatory departments along with third party suppliers, and vendors to deliver the required objectives.Every day, we rise to the challenge to make a difference and here's how the Senior Validation Specialist role will make an impact:Plan, lead and execute complex projects from initial concept to final validation.Act as the Validation Lead on complex validation projects.Act as Validation Manager designee when required.Review and approve validation protocols and reportsManage validation process through New Product Introduction Process (NPI) as required.Provide guidance and support and technical expertise to the validation group in allocated projects as required.Ensure that all validation activities are adhered to and closed as per the stage and gate process for site projects.Coordinate team activities to ensure schedule adherence, site permanent inspection readiness and continued site compliance.Present validation systems at internal and external audits and support quality assurance programmes in conjunction with the Validation Manager.Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.You will be required to be flexible in this position and must be prepared to undertake such other work as may be assigned to you by the company from time to time.
You may be asked to work overtime subject to departmental needs.About Your Skills & ExperienceFor this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Minimum of a Bachelor's Degree in a Technical, Science, Production or Process discipline and a minimum of six (6)years' experience in a validation role within the Pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes.Knowledge of Pharma/Medical product manufacturing, especially sterilisation processes and/or filling operations.Experience in process, software, filling and sterilisation process validation.Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements.Experience with statistical software packages.Ability to understand manufacturing processes.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.Act in supervisory capacity for the validation team and review and approve validation documentation.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 ViatrisAt 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 opportunitiesWork-life balance initiativesBonus schemeHealth insurancePensionDiversity & Inclusion at ViatrisAt 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 ViatrisCorporate 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 At 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.
