Job Purpose
Provide strong technical expertise and leadership in Process Development for project transfer and start-up. Work closely with teams 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 activities for project implementation to deliver results within projected timeline, excellent execution and documentation
• To lead and coordinate operational team on site and ensure line availability
• To provide technical provision, operation and availability of modules and line for studies, qualification and validation
• To support 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 run / 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
