We are looking for a 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. Your work will directly contribute to maintaining a safe, efficient, and compliant manufacturing environment.
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.
Required Skills, Experience, and Education
Bachelor's degree in Science, Engineering, or a related technical field.
At least 2 years of relevant experience, preferably in an aseptic manufacturing or cell therapy environment.
Strong knowledge of cGMP regulations, FDA/EU guidelines, and Good Tissue Practices (cGTP).
Expertise in CQV processes, process optimization, and regulatory compliance.
Experience working with batch records, SOPs, CQV protocols, and technical documentation.
Excellent analytical, organizational, and communication skills.
Familiarity with TrackWise, Comet, CMMS, Veeva, Maximo, Kneat, Kay, and AVS/Validator is a plus.
Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).