What are the responsibilities and job description for the Cell Therapy Manufacturing Lead position at SciPro?
About the Role
We are seeking a skilled CQV Engineer to play a key role in ensuring the safety, quality, and compliance of our cGMP Clinical and Commercial Cell Therapy Manufacturing facility.
In this position, you will lead commissioning, qualification, and validation (CQV) activities for facilities, equipment, systems, and processes—supporting the reliable production of personalized cell therapies.
Key Responsibilities:
- Perform commissioning, qualification, validation, and maintenance activities within the facility.
- Oversee multiple CQV projects, providing updates and coordinating with internal teams and external vendors.
- Lead and support quality investigations, CAPAs, and process improvements to enhance compliance and efficiency.
- Develop and implement remediation efforts and CAPA plans to resolve issues.
- Author and manage CQV protocols, summary reports, change controls, SOPs, and technical documentation.
- Contribute to risk assessments, FMEAs, project planning, master plans, and annual product reviews.
- Collaborate closely with Quality, Manufacturing Operations, Facilities & Engineering, Supply Chain, and other teams to drive success.
