Engineer

• Project Lead for Process Validation and/or Tech Transfer activities of late-stage molecule/ commercial manufacturing and/or PPQ campaign support
• Support technology transfer activities ensuring process gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations
• In collaboration with cross functional teams, develop Process Validation Master Plans, provide process knowledge to support Process Characterization, and perform Process Validation risk assessments
• Support development, review and approval of technical documentation including global protocols for Process Performance Qualification runs, Process Validation studies, and associated reports related to engineering, GMP and PPQ runs
• Support the development and implementation of templates for Process Validation and Continued Process Verification strategies
• Support the generation of governance policies and related SOPs for Process Validation
• Manage project-specific deliverables including but not limited to PVMP, PPQ protocols and supporting validation such as mixing, hold time studies, impurity clearance, extractables & leachables, filter validation etc.
• Support technology transfer activities ensuring process gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations
• Support the analysis of process data including annual periodic reviews across the network of Manufacturing sites

Senior Process Validation Engineer

Tooling Engineer

Process Engineer III

Validation Engineer II

Senior Process Validation Engineer