Job Purpose
Provide strong technical expertise and leadership in Process Development of project transfer and start-up. Responsible for areas of the Frontend processes. Work closely with team to ensure successful implementation of project. Lead and/or support the team for new product transfer I development, equipment design, processes optimization and qualifications efforts. To ensure compliance to ISO/FDA, cGMPs, HSE regulatory requirements.
Accountabilities
• To lead 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: 8-15 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.
