Director of Technical Services

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

As a member of the Galway Senior Leadership Team, the Director of Technical Services will be responsible for leading the execution of new product introduction and tech transfers for the Viatris Galway sterile drug product and packaging facilities.

Key Responsibilities

• Lead, coach and mentor a team of engineers and scientists to provide life cycle management oversight, validation and NPI/TT activities for the site/s, including investigations, product, compliance audits, process monitoring, and requalification.
• Provide leadership in driving resolution of complex investigations for deviations and customer complaints.
• Process Improvement:  Working with OpEx, drive continuous process improvement initiatives to enhance process robustness, cycle time reduction, yield optimizations, alternate source qualifications etc.
• Regulatory Compliance: Maintain a deep understanding of current regulatory guidance including EU Annex 1.  Provide ongoing technical support during regulatory audits and ensure adherence to Quality Management System (QMS) topics pertinent to PTO operations.
• Team Leadership and Development:  Manage a team of engineers by setting priorities and developing individual career development plans. Foster an inclusive work environment that emphasizes professional growth, collaboration, and technical excellence.
• Technical Expertise:  Act as the subject matter expert (SME) for sterile fill-finish unit operations, process engineering and process design.
• Ensure successful implementation of new technologies and practices that enhance operational robustness and cost efficiency.
• Cross-Functional Collaboration:  Work closely with cross-functional teams including R&D, QA, DP and packaging operations ) and other site groups, to align priorities, share best practices, and drive strategic initiatives aimed at business transformation and risk mitigation.
• Support strategic initiatives activities to enhance site performance metrics and provides expert knowledge to the site and across our company global technical network (while leveraging on other site experiences/ knowledge).
• Safety Leadership: Uphold and promote Environmental, Health & Safety (EHS) standards by participating in safety walks, process hazard analyses, and ensuring compliance throughout all operations.
• Documentation and Compliance: Oversee the writing and review of SOPs, gap analyses, and job aids to ensure compliance with corporate policies and guidelines

About Your Skills & Experience

• Bachelor's or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or other related field
• PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred
• Min 8 years’ experience in technical operations, technical services
• Experience leading TT and NPI in sterile fill finish, lyo and packaging areas
• Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
• Able to utilize digital and statistical tools for proactive process analysis monitoring.
• Aseptic Process Expertise, proven experience in contamination control strategies, in