Manager, CSV Cell Therapy
Core
Managing the qualification, validation, and lifecycle of manufacturing and laboratory equipment and computerized systems in a cell therapy environment.
Role type
Manager, CSV Cell Therapy (Manufacturing Systems & Validation)
Builds
Qualified and validated equipment, computerized systems, and validation documentation for pharmaceutical manufacturing and laboratory processes.
Domain
Pharmaceutical manufacturing / Cell therapy / GMP / Computerized Systems Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGXP requirements, 21 CFR Part 11 compliance, SDLC principles, equipment qualification, validation protocols, change control management, technical writing, project management, vendor supervision, regulatory audit support
Preferred skills
ISPE guidance knowledge, pharmaceutical laboratory systems expertise, MS Windows client/server technologies, Microsoft Office Suite proficiency
Technologies
MS Windows, Microsoft Office Suite (Word, Excel, Visio, Outlook)
Responsibilities
Support equipment qualification and validation activities; Investigate and resolve deviations and CAPA; Configure and document computerized systems for CFR21 Part 11 compliance; Supervise vendors for qualification functions; Manage projects of moderate scope and complexity; Act as SME in internal and regulatory audits
Seniority
Manager, hands-on leadership with team supervision
