From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.
Responsibilities
Develop manufacturing processes, procedures, and production layouts tailored to assemblies, equipment installation, processing, machining, and material handling in medical device manufacturing.
Spearhead and conduct equipment validations along with comprehensive reports, encompassing IQ, OQ, PQ, and Test Method Validation
Innovate manufacturing processes aligned with statistical process control, including the development of relevant techniques.
Offer expertise to engineering teams on design concepts and specification requirements for optimized equipment utilization and manufacturing techniques.
Ensure strict adherence to regulatory compliance by overseeing processes and procedures.
Maintain and revise documentation pertaining to manufacturing operations, encompassing work instructions, procedures, SOPs, P& ID flows, and associated change controls within the medical device manufacturing environment.
Requirements
Minimum of 4 years of relevant experience in the field.
Experience in Design Verification Testing
Strong mechanical and/or electrical aptitude.
Experience utilizing CAD/Solidworks for design and custom tooling
Knowledge of manufacturing environments and assembly processes.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Pharmaceutical Manufacturing
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