Manufacturing Engineer

Manufacturing Engineer

Location: Worcester, MA

Department: Azzur Consulting LLC

Job Description

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.

• Proficiency in Geometric Dimensioning and Tolerancing (GD&T).

• Strong mechanical and/or electrical aptitude.

• Knowledge of manufacturing environments and assembly processes.

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