Establish new and/or transfer existing DOM (Diagnostics Operations Mannheim) Technical requirements and SOPs to fit Asia Manufacturing (AM) needs
As technical SME of electrical and automation, responsible for define and keep optimizing the PM task of electrical and automation system
Responsible for complex automation and electrical problem solving, provide technical solution for M&R technician, lead electrical and automation modification and improvement
Responsible for automation system maintenance, including but not limited to system programming backup and recovery, software system diagnosis and maintenance
Lead or support for the new automated process equipment project from procurement, installation, validation, calibration, and maintenance
Technical training for maintenance technicians
As technical coordinator and contact window with IT team
Participate in the design and implementation of new equipment according to divisional and local standards.
Support or lead improvement or CAPEX from commissioning to qualification (SAT/FAT/IQ/ OQ/PQ).
Participate in the OEE team identify and implement improvements to equipment and equipment maintenance and documentation, to minimize unscheduled downtime and increase OEE
As lead user of OSI-PI system, be responsible for the new user training process
Provide technical support for site automation strategy plan and execution
Other tasks assigned by head of department
Qualification & Experience
Technical education background, major in mechanical and electrical engineering
Electrical and Automation education or equivalent by experience
Bachelor or above degree in Electrical and Automation or equivalent by experience
Experience
1. > 3 years working experience in a high regulated manufacturing site
2. Equipment management experience
Preferred
1.Working experience in compounding, filling or packaging areas
2. New production equipment qualification and validation experience is a plus
3. Line manager experience
Professional Competencies
1. Familiar with problem solving methods
2. Experience in SAP PM Module
3. Knowledge of TPM (total productive maintenance) methodology is recommended.
4. Strong Automation background and good understanding of the GAMP5 guidelines.
5. Familiar with CFDA Medical Device GMP
6. Good experience on OSI-PI system
7. experience in a highly regulated cGMP manufacturing environment.
Languages
CET-4 or above
Proficient in English for professional workplace communication
Leadership Competencies
Leadership competencies at proficient level, in line with corporate framework.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.