Sr. Validation Engineer
Core
Lead complex validation projects for equipment, processes, utilities, and computer systems in pharmaceutical manufacturing to ensure product quality and regulatory compliance.
Role type
Senior Validation Engineer (Pharmaceutical Manufacturing)
Builds
Validated manufacturing equipment, utilities, cleaning processes, and computer systems for pharmaceutical operations
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
Validation protocols (IQ/OQ/PQ), Risk assessment, Statistical analysis, Root cause analysis, Technical writing, Cross-functional team leadership, Cleanroom operations, Electronics microscope operation (SEM/FIB/TEM)
Preferred skills
Regulatory inspection experience, Client audit support, Advanced degree in Material/Life Sciences/Chemistry
Technologies
MS Office, Statistical packages, Validation systems
Responsibilities
Lead complex validation projects for equipment, processes, utilities, and computer systems; Execute validation protocols and documentation; Collaborate with cross-functional teams to maintain GMP standards; Support client and regulatory audits; Contribute to continuous improvement initiatives
Seniority
Senior, hands-on IC
