Principal QA Validation Specialist (Fill Finish)
Core
Lead validation and qualification of utilities, cleanrooms, and filling lines for commercial pharmaceutical production, ensuring regulatory compliance and contamination control.
Role type
Principal QA Validation Specialist (Fill Finish)
Builds
Qualified utilities, cleanrooms, and filling lines for commercial production
Domain
Pharmaceutical manufacturing / Fill Finish / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP validation, utility qualification, environmental monitoring, change control management, CAPA/NOE review, audit leadership, HACCP assessments, contamination investigation, policy creation, team management
Preferred skills
cross-functional collaboration, gowning in manufacturing areas
Technologies
WFI, pharmaceutical air, AHUs, clean steam generators, nitrogen distribution systems
Responsibilities
Lead validation and serve as SME for utilities and environmental qualification; Plan and execute cleanroom qualifications and requalification; Drive QRM deliverables including HACCP assessments; Lead investigations of contamination events; Qualify critical utilities; Manage and develop a specialist and a team of consultants; Establish processes for regulatory compliance; Influence creation and revision of local/global policies
Seniority
Principal, hands-on IC with team leadership
