Process Engineer

5 days ago

Fair Lawn, United States Katalyst HealthCares & Life Sciences Full time

Job Description: The Quality Process Engineer will be responsible for developing and maintaining process control systems to ensure consistent product quality, with a focus on supporting the insourcing of materials and components. This role leads cross-functional efforts to qualify internal processes, validate materials, and transition manufacturing activities from external suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving process improvements, supporting investigations, and managing documentation throughout the insourcing lifecycle. Supporting Insourcing of different vendor chemicals or suppliers. HEAVY on the insourcing aspects. 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 (, 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 (, 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. Requirements: Bachelor's degree in engineering, Chemistry, Life Sciences, or related technical field. + years of experience in quality, process engineering, or manufacturing environment, preferably in a regulated industry. Strong understanding of GMP, GDP, and FDA quality system regulations. Demonstrated ability to lead cross-functional projects and manage multiple priorities. Excellent written and verbal communication skills. Proficiency in technical writing and documentation control systems. Experience with validation, process transfer, or insourcing/technology transfer is highly preferred.

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