- As the Validation Lead you will be responsible for providing validation oversight and take full ownership of the validation requalification and/or projects supporting the manufacturing operations.
- Lead a team of Validation Engineers in the completion of validation activities providing guidance and direction in the preparation and execution of validation activities, such as process validation, equipment/utilities/facilities qualification, sterilization validation and cleaning validation.
- Act as a key member of multi-department teams as the Validation Subject Matter Expert (SME) bringing new products/processes on-line or troubleshooting and/or improving existing products/processes.
- Lead validation efforts with cross functional teams to deliver Validation projects and to schedule.
- Support in execution of validation/qualification studies when required.
- Contribute in areas such as regulatory submissions, change control, periodic review, investigation/deviation management, CAPA's, policy writing and Validation Master Plan's.
- Present validation systems at internal and external audits and support quality assurance programmes in conjunction with the Validation Management.
- Conduct validation activities in compliance with US and EU regulations, ISO standards, Corporate Policies and EHS requirements.
- Support and develop direct reports to ensure their training and development needs are met and encourage their continued growth within the organisation.
- Perform other duties when required.
- Minimum of a Bachelor's degree (or equivalent) in Science or Engineering and 5+years' experience in a pharmaceutical or medical device manufacturing facility. Experience of people management and project management will be a distinct advantage. However, a combination of experience and/or education will be taken into consideration.
- Must possess knowledge of pharmaceutical and/or medical device regulatory requirement for FDA and IMB regulated environments.
- Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
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Lead Validation Engineer - Inverin, Ireland - Viatris
Description
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 Lead Validation Engineer will lead a team to successfully deliver the validation programme of activities in support of manufacturing operations within Mylan Teoranta, a Viatris Company and coordinate the development and maintenance of the company's validation program in compliance with all applicable regulatory and company requirements. Every day, we rise to the challenge to make a difference and here's how the Lead Validation Engineer role will make an impact:
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:
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:
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
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
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.
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