MS&T and Validation Lead (m/f/x)
On-site · Marburg an der Lahn, Hesse, Germany
Job Summary
Lead MS&T, Process Technology, and Validation activities for parenteral manufacturing across Plasma Fractionation, Bulk Purification, Formulation, Aseptic Filling, and Packaging; manage a cross-functional team in a matrix organization to ensure site processes are validated and compliant with regulatory requirements; drive process robustness, QbD-based lifecycle management, CAPA investigations, and regulatory inspections; oversee project lifecycles for capacity expansion and compliance while coordinating with global teams and site leadership.
Required Qualifications
- Education Undergraduate/graduate degree in Engineering or related technical field
- 10+ years working in Engineering, Process Development, or Validation of biopharmaceutical products and processes in Pharmaceutical, Chemical Manufacturing or similar industry
- Demonstrated experience in process monitoring, analytics, and improvement development & execution
- 5+ years of experience managing and working within a global matrix organization
- Strong understanding of biopharmaceutical operations and GMP regulations and regulatory guidance
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