Process Lead Engineer

1. Engage in the team build up, induction, training & qualification and development within the department. Work out SOPs and the training materials, technical and production document. Technical training for System reagent technicians.

2. Ensure all system reagent related tasks are in compliance including quality and safety requirements. As the SME of chemical materials, provide technical expertise of handle chemical materials.
3. Assess, and develop new and/or transfer existing System reagent Technical requirements and SOPs to fit RDSZ needs and ensure that these requirements are defined with clear roles and responsibilities for the operation team of System reagent.
4. As technical SME of System reagent, engage in optimization on manufacturing process & related equipment system.
5. Responsible for systematic investigation and analysis for common process issues and providing technical solution.

6. In collaboration with respective service provider, supply chain, facility management, equipment maintenance and project teams, lead or support project of manufacturing capacity expansion or efficiency improvement.

7. Working on deviation reports (e.g. out of specification, events, deviations, CAPA-Processes).

8. Coordinate or support on equipment FAT, SAT, IQ/OQ, PQ and process validation. Ensure production equipment, processes are qualified and validated.

9. Assessment and management of product quality data (Trend analysis).  Lead or support on triggering correct & preventive action and improvement project for quality compliance and operation optimization.

10. Technical support on the cooperation with the interfaces (e.g. sending site , QC, R&D, international supplier) on product issue solution, decision on action and implementation.

11. Execution of system and process analysis in preparation to IT projects as well as optimization of the existing system landscape.

12. Other tasks assigned by line manager.

罗氏是一家提供均等机会的雇主。