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 with 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
Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
Experience leading technical projects and managing timelines with external collaborators and vendors
Candidate must possess a strong focus on quality and attention to detail as well as effective task/ time management organizational skills
Understanding of biologics manufacturing process and process automation (e.g. DeltaV) (preferred)
Experience with single-use technologies and systems (preferred)
Previous work experience with Complex Equipment, Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES (preferred)

Validation Engineer II

Key skills