Senior Specialist, Validation Engineer II
Core
Qualifies and validates manufacturing, laboratory equipment, facilities, and utilities to ensure they remain in a qualified state for biologics/cell therapy production.
Role type
Senior Specialist Validation Engineer (Manufacturing/Utilities)
Builds
Qualified equipment, facilities, and utility systems for biologics/cell therapy manufacturing
Domain
Pharmaceutical manufacturing (Biologics/Cell Therapy)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (validated equipment/facilities)
Required skills
cGMP knowledge, equipment qualification, facility validation, utility validation, temperature mapping, change management, regulatory compliance (FDA/EMA/ICH), project management, technical writing, risk assessment, CAPA management
Preferred skills
Distributed control systems (GAMP), automation validation, lean principles, Six Sigma, process control systems, laboratory instrumentation
Technologies
GAMP, distributed control systems, automation systems, laboratory instrumentation
Responsibilities
Develop and execute validation plans, requirements specifications, and traceability matrices; Ensure periodic reviews and requalification; Author and review SOPs, work protocols, and validation deliverables; Manage validation lifecycle including change controls and shutdown/changeover; Execute limited scope validation projects under strict deadlines; Provide technical support and guidance on qualification issues; Contribute to regulatory inspection readiness
Seniority
Senior Specialist, hands-on IC with moderate complexity project ownership
