Packaging Process Engineer

Responsibilities

• 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.
• Cook up coordination 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.
• Afford assessment process steps and perform failure analysis for assembly/manufacturing process.
• Adapt machine or product design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate 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.
• 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.

Qualifications

• Familiarity with high volume packaging equipment (FFS, bar sealer, alloyd)
• Strong knowledge of PDR, OQ, IQ, PQ
• Project Management - Develop project deliverables and timelines for execution