Engineer

• Execute FUSE commissioning and validation activities for early stage clinical manufacturing, late-stage molecule/ commercial manufacturing and/or PPQ campaign support
• Generate and review technical documentation including validation lifecycle documents, validation protocols and associated reports related to the equipment validation lifecycle
• In collaboration with cross functional teams, develop Validation Master Plans, provide process knowledge to support the validation execution and risk assessments
• Lead the development and implementation of templates and validation workflows
• Support the generation of governance policies and related SOPs for commissioning of FUSE
• Support validation deviation resolution including troubleshooting and root cause analysis
• Support the periodic review of qualified/validated FUSE across JUST WA sites
• Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings

Validation Engineer II

Tooling Engineer

Process Engineer III

Senior Process Validation Engineer

Senior Process Validation Engineer