Senior Specialist, Validation Engineer II
Core
Qualifies and validates manufacturing equipment, facilities, utilities, and computer systems for biologics/cell therapy production to ensure compliance with cGMP and regulatory standards.
Role type
Senior Specialist Validation Engineer (Pharmaceutical Manufacturing)
Builds
Qualified and validated equipment, facilities, and utilities for biologics/cell therapy manufacturing
Domain
Pharmaceutical manufacturing / Biologics / Cell therapy / cGMP
Required skills
cGMP knowledge, equipment qualification, facility validation, utility validation, temperature mapping, distributed control systems (GAMP), regulatory guidelines (FDA/EMA/ICH), change management, risk assessment, CAPA management, technical writing, project management
Preferred skills
Lean principles, Six Sigma, automation validation, multi-product facility lifecycle management
Technologies
GAMP, distributed control systems, laboratory instrumentation, manufacturing process control systems
Responsibilities
Develop and execute validation plans, requirements specifications, traceability matrices, and summary reports; Ensure periodic reviews and requalification; Support equipment qualification and validation activities; Author and review SOPs, work procedures, and test protocols; Manage validation lifecycle maintenance including document hierarchy and change controls; 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