Technical Services Lead: Sterile Process Validation

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

Benefits offered by this job

Career progression

Work-life balance

Bonus

Job summary

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,

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 (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.

Skills

Aseptic processing

Process validation (PPQ)

Scale-up

CPPs & CQAs

Cross-functional leadership

Project management

Root cause analysis

Analytical thinking

Education

Bachelor's or Master's in Pharmaceutical Science

Chemical/Biochemical Engineering

Tools

Minitab

Job description

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,