Technical Services Lead

Viatris; Inverin; Presencial; EUR 110.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career progression

Work-life balance

Bonus

Descripción de la vacante

Viatris in Ireland seeks a Technical Services Lead to support a 3-year commercialization program for a new cartridge-filling product line. You will drive aseptic manufacturing process development, transfer, and optimization while ensuring cGMP compliance and regulatory expectations.

You will lead PPQ and ongoing process verification for sterile drug products, define CPPs/CQAs, manage risk assessments, analyze data for yield improvements, and collaborate with R&D, Manufacturing, Quality,

Formación

• Bachelor's or Master's degree in Pharmaceutical Science, Chemical/Biochemical Engineering, or related field.
• Experience in pharmaceutical process development, technical services, or manufacturing, ideally in sterile injectables.
• Project Management Certification (would be an advantage).
• Strong knowledge of aseptic processing, process validation (PPQ), and scale-up.
• Experience with DOE, SPC, and process modeling tools (e.g., Minitab).
• Deep understanding of CPPs, CQAs, and control strategy design.
• Knowledge of microbiological principles and sterility assurance.
• Excellent analytical, problem-solving, and leadership skills.
• Proven ability to lead cross-functional teams and deliver complex technical projects.

Responsabilidades

• Lead process validation (PPQ) and ongoing process verification activities for sterile drug products.
• Ensure product and process-related technical services align with regulatory and internal standards.
• Lead design, development, and optimization of aseptic manufacturing processes for robustness, scalability, and efficiency.
• Define CPPs and CQAs for manufacturing processes.
• Initiate and lead process risk assessments (FMEA, Ishikawa) and implement risk mitigation strategies.
• Analyze process and performance data to identify trends, reduce variability, and improve yield.
• Support investigations, root cause analyses, and CAPA implementation for process deviations.
• Lead the technical aspects of scale-up, technology transfer, and commercialization of new products.
• Collaborate with R&D, Manufacturing, Quality, Engineering and Regulatory Affairs to ensure smooth transitions from development to commercial production.
• Provide SME-level input into process validation protocols, batch records, and regulatory documentation.
• Identify qualification and validation requirements for new product introductions.
• Stay current with evolving regulatory expectations (Annex 1, FDA, EMA, ICH Q8-Q10) and integrate best practices into process management.
• Ensure completion of PPQs, transfers, and process improvement projects within agreed timelines.
• Maintain zero critical/major audit findings related to process validation or robustness.
• Demonstrate measurable gains in process consistency, quality, and productivity.

Conocimientos

Aseptic processing

Process validation (PPQ)

Scale-up

CPPs & CQAs

Cross-functional leadership

Project management

Root cause analysis

Analytical thinking

Educación

Bachelor's or Master's in Pharmaceutical Science

Chemical/Biochemical Engineering

Herramientas

Minitab

Descripción del empleo

Mylan Teoranta 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

As Technical Services Lead , you will support the delivery of 3-year commercialization program for a new cartridge-filling product line and will be primarily responsible for activities related to product and process performance and for the design, development, transfer, and optimization of aseptic pharmaceutical manufacturing processes, while ensuring compliance with cGMP and global regulatory expectations while driving process robustness, efficiency, and continuous improvement.

Every day, we rise to the challenge to make a difference and here's how the Technical Services Lead role will make an impact:

• Lead process validation (PPQ) and ongoing process verification activities for sterile drug products
• Ensure product and process-related technical services align with regulatory and internal standards
• Lead design, development, and optimization of aseptic manufacturing processes for robustness, scalability, and efficiency
• Define critical process parameters (CPPs) and critical quality attributes (CQAs) for manufacturing processes
• Initiate and lead process risk assessments (FMEA, Ishikawa, etc.) and implement risk mitigation strategies
• Analyze process and performance data to identify trends, reduce variability, and improve yield
• Support investigations, root cause analyses, and CAPA implementation for process deviations or non-conformances
• Lead the technical aspects of scale-up, technology transfer, and commercialization of new products
• Collaborate with R&D, Manufacturing, Quality, Engineering and Regulatory Affairs to ensure smooth transitions from development to commercial production
• Provide SME-level input into process validation protocols, batch records, and regulatory documentation
• Identify qualification and validation requirements for new product introductions.
• Stay current with evolving regulatory expectations (Annex 1, FDA, EMA, ICH Q8-Q10) and integrate best practices into process management.
• Ensure completion of PPQs, transfers, and process improvement projects within agreed timelines
• Maintain zero critical/major audit findings related to process validation or robustness
• Demonstrate measurable gains in process consistency, quality, and productivity.

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 or Master's degree in Pharmaceutical Science, Chemical/Biochemical Engineering, or related field.
• Experience in pharmaceutical process development, technical services, or manufacturing, ideally in sterile injectables
• Project Management Certified (would be an advantage)
• Strong knowledge of aseptic processing, process validation (PPQ), and scale-up
• Experience with DOE, SPC, and process modeling tools (e.g., Minitab)
• Deep understanding of CPPs, CQAs, and control strategy design
• Knowledge of microbiological principles and sterility assurance
• Excellent analytical, problem-solving, and leadership skills
• Proven ability to lead cross-functional teams and deliver complex technical project

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