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.
瑞健集團(SHL)成立於1989年，目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今，在全球製藥及生物科技領域，SHL已成為藥物輸送系統的OEM/ODM領導製造商，如自動安全注射器。除此之外，SHL還擴展許多產品線，像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等，目標市場為北美、歐洲及亞洲。
【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.
How we hire
We like to keep things simple and efficient.
Once you’ve applied, it may take up to three weeks to review your application and get the first call with a recruiter.
Our recruitment process is focused on allowing you to show your personality, experience and competencies while giving you a great sense of who we are.
Grounded in belonging, we strive for excellence
With almost 6,000 employees of 77+ different nationalities, we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth. Together, we invest in our future to maintain our leadership position in drug delivery systems.
