• Develop, execute, and implement process validation strategies and concepts
• Support technical process transfers, for example from development to commercial-scale manufacturing
• Take end‑to‑end ownership of validation deliverables, including concept development, planning, execution, coordination of training and sampling, data evaluation, and report generation
• Plan and coordinate troubleshooting activities in collaboration with pilot facilities, manufacturing, and quality functions
• Manage deviations and change controls in compliance with GMP requirements
• Contribute to continuous improvement and optimization projects

Qualifications

• Degree (or equivalent experience) in a scientific or technical discipline, such as biotechnology, bioprocess engineering, or chemical engineering
• Experience working in a GMP‑regulated environment; exposure to process validation or characterization is advantageous