Job Description
- 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
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