Industrialization Engineer

Description

• End-to-End Process Ownership:
• Manage the entire lifecycle of manufacturing processes-from concept to production to phase-out.
• Ensure processes meet quality, cost, and delivery targets across the product lifecycle.
• New Product Introduction (NPI) and Continuous Improvement:
• Collaborate with R&D and vendors to ensure products are designed for manufacturability and scalability.
• Conduct validations and capability studies to confirm new processes meet requirements.
• Drive process improvements to increase yield, reduce scrap, and optimize equipment utilization.
• Lean Manufacturing & Automation:
• Apply Lean principles to minimize waste and improve productivity.
• Implement and troubleshoot automated systems to enhance efficiency and consistency.
• Integrate mechanical engineering concepts into manufacturing processes.
• Change Management and Quality Compliance:
• Lead change control processes, including updates to SOPs, manufacturing instructions, and calibration/maintenance procedures.
• Work closely with Quality, QC, and external vendors to ensure processes comply with regulatory requirements (e.g., ISO 9001/13485, cGMP).
• Investigate manufacturing quality events, develop root cause analyses, and implement corrective actions (CAPA).
• Collaboration and Cross-Functional Coordination:
• Coordinate with multiple departments-including Supply Chain, Maintenance, and Production-for project success.
• Act as the primary liaison with external vendors and suppliers for equipment procurement and process changes.
• Participate in cross-site initiatives and provide insights on industrial hygiene practices.
• Performance Monitoring and Data-Driven Decision Making:
• Track key performance metrics (e.g., OEE, yield, scrap rate) and predict trends for proactive improvements.
• Utilize data analytics tools (e.g., Excel, ERP/MES) to generate actionable reports and dashboards.
• Training and Knowledge Transfer:
• Develop and deliver training sessions for operators and technicians on new or improved processes and technologies.
• Mentor junior engineers or team members involved in process improvement initiatives.

• Bachelor's Degree required. BS in Mechanical Engineering, Industrial Engineering, or a related discipline is preferred.
• 2+ years of experience in a cGMP manufacturing environment.
• Proven track record in managing New Product Introduction (NPI) and continuous improvement projects.
• Experience working with automated systems, mechanical engineering, and industrial hygiene principles.
• Familiarity with Lean manufacturing methodologies and change control processes.

• Strong analytical, problem-solving, and project management skills.
• Excellent communication and technical writing abilities.
• Ability to collaborate effectively with cross-functional and external partners.
• Familiarity with MES/ERP systems and data analytics tools is preferred.