Validation Engineer II (Cleaning)
Core
Ensuring risk-based cleaning validation policies and standards adhere to GMP standards and AbbVie procedures for API and Biologics manufacturing facilities.
Role type
Validation Engineer II (Cleaning)
Builds
Validated cleaning processes and equipment qualification for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing (API and Biologics)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Knowledge of pharmaceutical regulatory requirements (GMP), Risk Based Cleaning Validation Lifecycle, Equipment Qualification, Protocol generation and execution, Trend analysis, CAPA identification and closure, Change management, Deviation handling
Preferred skills
Experience with start-ups and brownfield projects, Hands-on experience in establishment and maintenance of Equipment Qualification supporting cleaning activity
Technologies
GMP, Risk Based Cleaning Validation Lifecycle, Equipment Qualification
Responsibilities
Adhere to validation master plans and execution plans for cleaning validation, Generate and review protocols for initial and re-qualification programs, Support development of specifications and strategies for equipment cleanability, Coordinate risk-based cleaning validation activities, Analyze trends and resolve issues impacting validated status, Provide guidance to Manufacturing and O&M personnel on cleaning challenges, Support cross-functional teams in quality oversight, Support cleaning validation during inspections and audits
Seniority
Mid-level, hands-on IC
