Sr. Principal Quality Engineer
Core
Develop and execute standardized cleaning validation protocols and master plans for FDA-registered pharmaceutical packaging facilities to ensure compliance with regulatory standards.
Role type
Senior IC Quality Engineer (Cleaning Validation)
Builds
Validated cleaning processes and protocols for pharmaceutical packaging
Domain
Healthcare / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cleaning validation protocol design, risk assessment, residue/contaminant acceptance criteria establishment, lifecycle management of validated processes, cross-functional collaboration
Preferred skills
Master plan development, scientific justification of criteria, mentorship
Technologies
None stated
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
Seniority
Senior, hands-on IC with mentorship responsibilities
