Validation Specialist ( 18 Months Agency Contract )

1100 Mylan Pharmaceuticals Inc.; Mulhuddart; On-site; EUR 55,000 - 75,000; Full time

Job summary

Viatris is seeking a Validation Specialist to drive process validation/qualification across multiple production areas, including writing, executing and reporting validation activities in a cGMP environment.

Ideal candidates will have a Bachelor's degree in a relevant field, hands-on validation experience, and strong technical writing and communication skills to collaborate with project teams and manage multiple priorities.

Qualifications

• Bachelor's degree in Science, Engineering, Technology or a related discipline.
• Hands-on experience working as a validation engineer/specialist in a cGMP environment, preferably in an oral solid dose facility.
• 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.

Responsibilities

• Process Validation/Qualification projects across a range of production areas (Process, Cleaning, Software, Utility and Facility).
• Generation, execution and close out of validation projects for existing products and new product introductions.
• Writing, executing & reporting of validation activities (FAT / IQ / OQ / PQ / FMEA Risk Assessments / PVP).
• Participate in project teams and assist in determining schedules and levels of validation.
• Execute and document risk assessments (FMEA) related to validation activities.
• Perform validation functional testing as required.
• Track and resolve deviations during qualification activities.

Skills

Validation engineering

cGMP experience

Technical writing

Communication

Education

Bachelor's degree in Science, Engineering, Technology or related discipline

Job description

Rottapharm Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. 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. 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. Hands-on experience working as a validation engineer/specialist in a cGMP environment, preferably in an oral solid dose facility. 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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.