What are the responsibilities and job description for the Cell Therapy Manufacturing Specialist position at SciPro?
About SciPro
We are a biopharmaceutical company dedicated to advancing cell therapy manufacturing. Our mission is to deliver high-quality, compliant products that improve patient lives.
As a CQV Engineer, you will play a critical role in ensuring the safety, quality, and compliance of our cGMP Clinical and Commercial Cell Therapy Manufacturing facility.
Key Responsibilities:
- Commissioning, qualification, validation, and maintenance activities within the facility.
- Oversight of multiple CQV projects, providing updates and coordinating with internal teams and external vendors.
- Leadership and support for quality investigations, CAPAs, and process improvements to enhance compliance and efficiency.
- Development and implementation of remediation efforts and CAPA plans to resolve issues.
- Authorship and management of CQV protocols, summary reports, change controls, SOPs, and technical documentation.
- Contribution to risk assessments, FMEAs, project planning, master plans, and annual product reviews.
