Job
Provide input to solve complex problems including, but not limited to, those related to process, equipment, documentation, equipment validation, Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ).
Prepare, review, and approve manufacturing instruction, protocols, reports, and other controlled documentation.
Coordinate with other departments to understand automation, assembly, packaging, process engineering, quality, regulatory, effectiveness, and timeliness of the product/process and production flow process and make sure the manufactured product is following regulatory quality standards.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Assess process steps and perform failure analysis for assembly/manufacturing process.
Adapts machine or product design to factory and production conditions.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
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Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures are in compliance with regulations.
Interface with senior management and cross functional team to assign deliverables and communicate / report progress. Receive strategic updates impacting the projects.
Top 3 technical skills that are required for the role
1) Familiarity with high volume packaging equipment (FFS, bar sealer, alloyd)
2) Strong knowledge of PDR, OQ, IQ, PQ
3) Project Management – Develop project deliverables and timelines for execution
