SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.
(SHL)1989,,,SHLOEM/ODM,,SHL, ,
Job Overview
The Validation Engineer is responsible for validating all equipment and injection molding tool used in injection molding related process, including resin incoming inspection equipment, measurement equipment, etc.
Main Responsibilities
- Responsible for following all applicable SOPs and Work Instructions at all times.
- Responsible for following the principle of GMP to the best of their ability at all times.
- Evaluate the necessity of validation activity and design/discuss validation scale/approach according to the validation policy in SHL with internal and external stakeholders/vendors.
- Generate validation plan and reports.
- Establish validation agenda and arrange validation runs, testing, and metrology.
- Implement tool or equipment/process validation activities with all supporting units and collect the related test results.
- Participate in deviation handling led by investigation leader and come up with action plans and proceed further validation activities accordingly.
- Provide audit materials of validation execution level.
- Able to introduce validation concepts/designed approach to internal/external auditors or customers.
- Carry out other duties as assigned.
- Business travel is required.
