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

Bachelor’s degree in engineering science or related program
Minimum 2 years relevant experience
Proven experience in executing commissioning and validation activities of FUSE
Understanding of GMP concepts and Quality systems necessary to execute validation activities
Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and/or facilities
Knowledge of process equipment, utilities, operations, and engineering principles
Experience in quality risk management
Must possess problem-solving and critical thinking skills
Good interpersonal, team, and collaborative skills
Motivated, self-starter with strong mechanical aptitude
Experience leading technical projects and managing timelines with external collaborators and vendors

Validation Engineer II

Key skills