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 (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.
• Culture and Expectations.
• Dress Code: Business Casual.
• Work Environment: Combination of office work, lab work, and manufacturing floor work.
• Safety Equipment Provided by client: Safety glasses, lab coats, steel toe shoes, safety vests (used as needed).

Requirements:

• Bachelor’s degree in engineering, Chemistry, Life Sciences, or related technical field.
• 3+ 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.
• Degrees and/or Certifications:
• Experience with validation, process transfer, or insourcing/technology transfer is highly preferred.

• 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.
• Culture and Expectations.
• Dress Code: Business Casual.
• Work Environment: Combination of office work, lab work, and manufacturing floor work.
• Safety Equipment Provided by client: Safety glasses, lab coats, steel toe shoes, safety vests (used as needed)