Transformation Project Qualification Lead- API
Core
Lead project teams to drive schedule, execution, risk management, and reporting for commissioning, qualification, and validation of new/modified equipment, facilities, utilities, and processes in line with project and quality objectives.
Role type
Senior IC project lead (commissioning, qualification, and validation)
Builds
Commissioning, qualification, and validation deliverables for manufacturing equipment and processes
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, risk management (FMEA), commissioning, qualification, validation, User Requirements Specifications, Functional/Design Specifications, Factory Acceptance Testing, troubleshooting, regulatory compliance, change control
Preferred skills
Supervisory experience, managing multiple complex projects, contract resource management, industry-specific knowledge (healthcare, pharmaceutical, medical devices)
Technologies
FMEA, Validation Master Plan, ccRA
Responsibilities
Develop User Requirements and Functional/Design Specifications; Support Factory Acceptance Testing; Identify risk controls and traceability; Develop and execute commissioning, qualification, and validation test protocols; Perform minor troubleshooting and document unresolved issues; Lead execution of Risk Management and periodic reviews; Supervise contract validation resources
Seniority
Senior, hands-on IC with supervisory responsibilities