Validation Engineering Specialist II
Core
Provide specialized validation knowledge and information to support operations and clients, with a main focus on Continuous Process Verification (CPV) for commercial manufacturing of conventional dosage forms.
Role type
Validation Engineering Specialist
Builds
Validated manufacturing and packaging processes for pharmaceutical clients
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
GMP/cGMP knowledge, FDA regulations, risk assessment, gap analysis, technical writing, data analysis, project management, statistical analysis, process control methods
Preferred skills
Minitab, JMP, PowerBI, Microsoft Fabric, AI, automation systems, computer system validation
Technologies
Minitab, JMP, PowerBI, Microsoft Fabric, Microsoft Office
Responsibilities
Compile and analyze batch records, prepare and execute validation protocols, monitor production scheduling, attend client meetings, assist in investigations and special studies, support special projects
Seniority
Mid-level, hands-on IC
