Aseptic Process & Validation Lead

Viatris; Connacht; On-site; EUR 95,000 - 135,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Excellent career progression

Job summary

Viatris is seeking a Technical Services Lead to support a 3-year commercialization program for a new cartridge-filling product line. The role focuses on product/process performance and the design, development, transfer, and optimization of aseptic pharmaceutical manufacturing processes following cGMP and regulatory expectations.

Daily activities include leading PPQ and ongoing verification, defining CPPs/CQAs, performing risk assessments, analyzing data to reduce variability, and driving

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 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

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 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.

Skills

Aseptic processing

Process validation

Leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s in Pharmaceutical Science

Master’s in Pharmaceutical Science

Tools

Minitab

DOE methodologies

Job description

Viatris is seeking a Technical Services Lead to support a 3-year commercialization program for a new cartridge-filling product line. The role focuses on product/process performance and the design, development, transfer, and optimization of aseptic pharmaceutical manufacturing processes following cGMP and regulatory expectations.

Daily activities include leading PPQ and ongoing verification, defining CPPs/CQAs, performing risk assessments, analyzing data to reduce variability, and driving