Staff Validation Engineer, Process and Cleaning
Core
Ensuring manufacturing processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a sterile/aseptic environment.
Role type
Staff Validation Engineer (Process and Cleaning)
Builds
Validated manufacturing and cleaning processes for sterile/aseptic products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation (PPQ), Cleaning validation, Risk-based approaches, Lifecycle validation, Data analysis, Technical writing, Regulatory compliance (cGMP), Change control management
Preferred skills
Sterile/aseptic environment experience, Cross-functional collaboration
Technologies
None stated
Responsibilities
Lead process validation (PPQ) and cleaning validation activities, Develop validation strategies for new and existing products and processes, Author and execute validation protocols and reports, Perform data analysis to support validation conclusions, Support change controls, deviations, and CAPAs, Ensure alignment with cGMP and regulatory expectations, Support internal and external audits and inspections
Seniority
Staff, hands-on IC
