Process and Cleaning Validation Lead, MSAT
Core
Lead process and cleaning validation for drug substance manufacturing in GMP-regulated facilities, ensuring quality and efficiency through technical expertise and cross-functional collaboration.
Role type
Process and Cleaning Validation Lead
Builds
Manufacturing processes and validation protocols for drug substances
Domain
Pharmaceutical/Biotech manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, Cleaning validation, cGMP regulations, Quality systems, Statistical analysis, Project management, Technical training, Problem-solving
Preferred skills
Chemical Engineering, Chemistry, Biochemistry, Biotechnology
Technologies
Microsoft Office suite
Responsibilities
Provide leadership in process and cleaning validation, Collaborate with cross-functional teams to execute manufacturing processes, Resolve complex technical challenges and conduct investigations, Implement continuous improvement initiatives, Mentor colleagues and provide technical training, Support manufacturing operations as needed
Seniority
Senior, hands-on IC
