Sr. Principal Quality Engineer
Core
Develop and execute standardized cleaning validation protocols and master plans for a contract pharmaceutical packaging facility to ensure regulatory compliance.
Role type
Senior Principal Quality Engineer (Validation)
Builds
Validated cleaning processes and protocols for pharmaceutical packaging operations
Domain
Healthcare / Contract Pharmaceutical Packaging
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cleaning validation protocol development, risk assessment, acceptance criteria establishment, lifecycle management of validated processes, cross-functional collaboration
Preferred skills
Experience running/executing cleaning validations, Quality validations experience
Responsibilities
Develop and execute cleaning validation master plans, protocols, and reports; Design cleaning validation studies based on risk assessments; Establish scientifically justified acceptance criteria for residues and contaminants; Support lifecycle management of validated cleaning processes; Provide ongoing support for PQ/PV execution, Environmental Monitoring, and Temperature Validation
Seniority
Senior, hands-on IC with mentorship responsibilities
