The Sr. Process Engineer I leads complete IQ/OQ/PQ validation activities of both thermoplastic and silicone injection molds working with all stakeholders including Engineering, Production and Quality.
• Troubleshoot molding processes to mitigate production defects
• Participate in design reviews of new tooling and equipment working with both external and internal injection mold makers
• Lead technology improvements that advance our molding processes for new and existing products.
• Prepare complete and accurate records/documentation of assigned project activities per the established Quality System and Validation Guidelines
• Participate in regular project meetings with customers and internally, publishes timely project updates, and follows-up continuously on all open critical path items
• Generate and maintain documentation for applicable internal processes and procedures, inspection criteria, Bill of Materials, Validation Protocols/Reports and other manufacturing and quality records
• Identify, initiate and implement technology improvements, which increase productivity and reduce scrap/reject rates through effective training of production personnel and process enhancements
• Maintain and improve product quality by performing and documenting robust root cause investigations and implementing effective corrective and preventive actions
• Develop and leverage product knowledge to ensure Critical Quality Attributes (CQAs) are consistently met EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Education Requirements
• Minimum: Bachelor degree in Engineering or related technical discipline
• Preferred: Bachelor degree in Plastics Engineering
• Minimum: 2 years experience in high volume molding and manufacturing environment
• Preferred: 2 years experience in medical device manufacturing or other highly regulated industry
• Working knowledge of Validation processes (IQ/OQ/PQ)
• Technical expertise in injection molding of thermoplastics related to Design for Manufacturability of molds, processing of thermoplastics, robotics, automation and hot runner system
• Comprehensive knowledge and thorough understanding of troubleshooting techniques for the injection molding process, machine, robot and auxiliaries.
•Experience with advanced processing techniques (eDart), robot programming, hot runner molds, tooling issue diagnostics, molding machine diagnostics, central material handling systems and color blending.
• Processing knowledge of Polycarbonate, Acrylic, ABS, Polysulfone, and various commodity resins
• Familiar with SPC methodologies and the scientific molding process.
• Data driven, disciplined, objective and detail oriented.
• Ability to read and interpret part and mold drawings
• Ability to work with minimal supervision and/or guidance
• Familiarity with statistical problem solving techniques
• Excellent organization and communication skills.
• Knowledge of FDA regulations and other international compliance standards
• Competency in the following software: MS Project, Excel, Word, PowerPoint
A little about us:
As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs.