Lead Aseptic Process & Tech Transfer Specialist

Viatris; Galway; On-site; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Excellent career progression

Pension

Bonus scheme

Work-life balance initiatives

Job summary

Viatris Ireland is seeking a Technical Services Lead to drive aseptic manufacturing process development, validation (PPQ), and scale-up for a new cartridge-filling line, ensuring cGMP compliance and process robustness.

You will lead cross-functional teams, define CPPs/CQAs, perform risk assessments, analyze data, and collaborate with R&D, Quality, Manufacturing, and Regulatory Affairs to deliver scalable, compliant production.

Qualifications

• 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.

Responsibilities

• 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 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 deviations.
• Lead technical aspects of scale-up, technology transfer, and commercialization of new products.
• Collaborate with R&D, Manufacturing, Quality, Engineering and Regulatory Affairs.
• Provide SME input into process validation protocols, batch records, and regulatory documentation.

Skills

Cross-functional leadership

Process validation (PPQ)

Aseptic processing

DOE

Minitab

Education

Bachelor's or Master's in Pharmaceutical Science/Engineering

Tools

Minitab

Job description

Viatris Ireland is seeking a Technical Services Lead to drive aseptic manufacturing process development, validation (PPQ), and scale-up for a new cartridge-filling line, ensuring cGMP compliance and process robustness.

You will lead cross-functional teams, define CPPs/CQAs, perform risk assessments, analyze data, and collaborate with R&D, Quality, Manufacturing, and Regulatory Affairs to deliver scalable, compliant production.