Process Engineer

Overview

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Responsibilities

• Develop, implement, and maintain process control systems to ensure consistent product quality and process efficiency, especially in areas impacted by insourced materials.
• Analyze production and supply chain processes to identify bottlenecks, deviations, and improvement opportunities related to the insourcing of components or materials.
• Collaborate with Quality Assurance, Product Development, Process Development, and Manufacturing teams to support the insourcing of materials by qualifying internal processes, materials, and suppliers.
• Lead and support cross-functional initiatives to transition manufacturing processes or materials from external suppliers to internal operations.
• Facilitate root cause analysis during quality investigations, particularly when introducing new internal processes or materials, and incorporate corrective and preventive actions.
• Develop and review technical documentation (e.g., batch records, material specifications, validation protocols) to support the qualification and validation of insourced materials.
• Coordinate with engineering and project teams to define inspection criteria, material acceptance standards, and validation procedures for internally sourced materials.
• Manage documentation routing, review cycles, and project tracking to ensure timely completion of insourcing projects.
• Prepare and route documentation for approval, ensuring adherence to Good Documentation Practices (GDP) and applicable regulatory requirements (e.g., FDA, GMP).
• Act as a liaison across internal teams (Manufacturing, Supply Chain, IT, Quality Control, etc.) to ensure seamless integration of insourced materials.
• Occasionally interface with external suppliers and partners during the transition period to gather technical data or resolve quality issues.
• Support execution of project plans related to material insourcing, ensuring actions, milestones, and deadlines are met.
• Provide training for team members on new processes or materials introduced through insourcing efforts.
• Ensure compliance with internal SOPs, GMP standards, GDP, and regulatory requirements during all phases of material insourcing and process control.

Qualifications

Seniority level

Employment type

J-18808-Ljbffr