Validation Engineering Specialist II – Equipment Engineering
Core
Provide specialized validation knowledge to support operations and clients by completing protocols for equipment, processes, and new products, and reviewing finished reports.
Role type
Validation Engineering Specialist II
Builds
Validation protocols and reports for process, packaging, or cleaning validation; risk assessments for Continued Process Verification; study reports for bulk hold and shipping.
Domain
Pharmaceutical/Biotechnological manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol development, statistical analysis, risk assessment, swab sampling coordination, GMP compliance, data collection, report preparation
Preferred skills
Statistical analysis, Mini-Tab, data analysis
Technologies
Microsoft Office, Mini-Tab
Responsibilities
Prepare validation protocols and reports for process, packaging, or cleaning validation; Monitor and coordinate manufacturing execution and provide trainings on validation protocols; Perform data collection, statistical analysis and prepare summary reports; Monitor and coordinate swab sampling activities for cleaning validation; Prepare risk assessment, protocols and reports for Continued Process Verification program; Prepare protocols and reports for bulk hold studies, shipping studies and other additional studies as and when required
Seniority
Mid-level, hands-on IC
