Process & Cleaning Validation Specialist - Fixed term (replacement for maternity leave)
Core
Evaluate and validate manufacturing processes, equipment cleaning procedures, and aseptic filling (Media Fill) for sterile products to ensure compliance with GMP and regulatory requirements.
Role type
Process & Cleaning Validation Specialist
Builds
Validated manufacturing processes, cleaning protocols, and aseptic filling procedures for sterile pharmaceutical products
Domain
Pharmaceutical manufacturing / Sterile production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, Cleaning validation, Aseptic filling processes, Risk management, GMP compliance, Lifecycle approach (Process Qualification & Continued Process Verification), Deviation handling, Documentation archiving
Preferred skills
Client service, Project Management, New product transfer support, Cross-contamination management
Technologies
Microsoft Office (Word, Excel)
Responsibilities
Draft validation protocols for cleaning, process, and media fill; verify periodic cleaning and aseptic filling; oversee validation batches and handle deviations; draft validation reports; support new product transfers and process performance qualification; participate in design and implementation of new processes.
Seniority
Mid-level, hands-on IC
