Process & Cleaning Validation Specialist I
Core
Evaluate and validate manufacturing processes, equipment cleaning procedures, and aseptic filling (Media Fill) to ensure compliance with regulatory requirements and GMP standards.
Role type
Process & Cleaning Validation Specialist
Builds
Validated manufacturing processes, cleaning protocols, and aseptic filling procedures for sterile products
Domain
Pharmaceutical manufacturing / Sterile production
Required skills
Pharmaceutical techniques, Pharmaceutical production, Aseptic Filling processes, Risk management, Process Validation, Cleaning Validation, Aseptic Process Simulation, GMP compliance, Protocol drafting
Preferred skills
Client service, Project Management, Microsoft Office
Technologies
Microsoft Office (Word, Excel)
Responsibilities
Draft validation protocols for cleaning, process, and media fill; ensure periodic cleaning verification; validate manufacturing processes using lifecycle approach; draft validation reports; support new product transfers; participate in design and implementation of new processes.
Seniority
Junior to Mid-level, hands-on IC
