Specialist Manufacturing 35937

PR·Juncosmid

Manufacturing & ProductionLean Manufacturing Specialist

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Quick Summary

Requirements Summary

Manufacturing Experience On the floor support to Assess process performance by observation of floor operations and review of performance data. Initiate, revise, and approve manufacturing procedures.

Technical Tools

Manufacturing & ProductionLean Manufacturing Specialist

Responsibilities

~2 min read

→Manufacturing Experience
→On the floor support to Assess process performance by observation of floor operations and review of performance data.
→Initiate, revise, and approve manufacturing procedures.
→Provide process troubleshooting support.
→Participate in the NPI process to assess requirements for documentation, materials, training.
→Assist manufacturing change owner on CCRB packages impacting the process
→Participate on the assessment or implementation of special projects or initiatives

→Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
→Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
→Provide troubleshooting support.
→Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
→Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
→Provide support of timely execution of the process monitoring quarterly reports.Non-Conformance and CAPA
→Ensure that all non-conformances are triaged within the established goal.
→Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal.
→Monitor and communicate incidents trends.
→Review equipment/system Root Cause Analysis investigations and support trend evaluations.
→Assist with generation of process validation protocols and reports and with the execution of the process validation.
→Support collection and analysis of process validation data.
→Participate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:
→Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
→Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
→Assist manufacturing change owner on CCRB packages impacting the process.

Education:

→Master’s + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience