What are the responsibilities and job description for the Senior Biotechnology Validation Specialist position at Legend Biotech US?
Legend Biotech US is a leading biotechnology company committed to advancing the field of cell therapy manufacturing. We are seeking a highly experienced Validation and Commissioning Expert to join our team.
Role Overview
- This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.
- Execute day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
Key Responsibilities
- Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
- Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
Required Skills and Qualifications
- A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
- A minimum of 6 years relevant work experience is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
We are an equal opportunity employer and welcome applications from diverse candidates. If you have the required skills and qualifications, please submit your application for consideration.
