Job Purpose
Provide strong technical expertise and leadership in Process Development of project transfer. Responsible for the overall development of the Molding process. Work closely with team to ensure successful implementation of project. Lead and/or support the team for transfer I development, equipment design, processes optimization and qualifications efforts. To ensure compliance to ISO/FDA, cGMPs, HSE regulatory requirements.
Accountabilities
• To lead the Molding process development aspects of project implementation to deliver results within projected timeline, excellent execution and documentation.
• To lead user requirement specification (URS) development for processes equipment and liaise with vendors on technical discussion.
• To lead design reviews for processes equipment and work with global/ R&D team to develop and transfer the technology to site.
• To develop and execute equipment and processes validation approach / plan.
• To lead and execute new equipment and processes installation, optimization, commissioning, qualification and validation.
• To proactively communicate project progress, key issues and any other critical topics in a timely manner to the appropriate management level and vendors.
• To ensure compliance to cGMPs, IS013485 / FDA, HSE, and policy requirements.
Requirements
- Education: Minimum Diploma in Engineering (Mechanical, Electrical, Automation)or relevant discipline or equivalent.
- Experience: 5-10 years working experience in contact lens or optical device manufacturing or similar environment.
- Good understanding of processes automation system, vision inspection system, robotics and GMP/GDP requirement.
- Good analytical and troubleshooting skill with systemic approach.
- Good leadership and management skills.
