PDAP - Assembly Process Validation Engineer

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】【職務概述】

The Assembly Process Validation Engineer is responsible for defining validation strategy and executing/coordinating validation activities required to launch new automation assembly equipment or assembly process into the production environment. The successful candidate will perform validation activities that include Assembly Equipment Qualification, and Process Validation of an integrated manufacturing system. Work with a cross functional team to introduce new manufacturing equipment, new process, or new technology to mass production.

組裝製程驗證工程師負責定義驗證策略並執行/協調驗證活動，以將新的自動化組裝設備或組裝製程導入生產線。成功的候選人將執行包括組裝設備確認和公司整體製造系統的製程確效在內的相關驗證活動。此工作將與跨職能團隊合作，導入新的製造設備、新製程或新技術至量產階段。

【Responsibilities】【職務內容】

• Validate new assembly equipment and/or processes in collaboration with a diverse functional engineering team.

 • Generate and sustain Verification/Validation protocols/reports (IQ, OQ, PQ, PV) and related technical documents to support the transfer of assembly equipment/process from development into mass production.

• Provide technical assessment and validation review/approval for changes regarding manufacturing equipment, assembly process and related standard operating procedures.

• Participate in design, development, commissioning, and qualification of automated manufacturing equipment.

• Assist in failure investigations and root cause analyses occurred during equipment qualification and process validation.

• Involve in the risk assessment (P-FMEA) of manufacturing equipment/process and provide input to the risk mitigation plan as validation engineer.

• Involve in internal and external audits.

• 與各職能工程團隊合作，驗證新的組裝設備、製程和/或設計。

 • 撰寫和維護驗證/報告（IQ, OQ, PQ, PV）和相關技術文件，以支持將組裝設備/製程從開發階段轉移到量產階段。

 • 就製造設備、組裝製造流程及相關標準操作程序的變更提供技術評估和驗證審查/批准。

• 參與自動化製造設備/機器的設計、開發、調機和驗證。

• 協助設備驗證或製程確效期間發生的相關的偏差調查和根本原因分析。

• 參與製造設備/製程的風險評估（P-FMEA），並作為驗證工程師向風險緩解計劃提供意見。

 • 參與內部和外部稽核。

【Qualification】【職務規範】

• Bachelor's degree in Mechanical Engineering, Materials Engineering, Medical Device Engineering with mechanical emphasis, Electrical Engineering, automotive engineering or related field.

• Strong data analysis skills utilizing software such as Minitab.

• Skilled in the use of Microsoft Office Suite

• Excellent verbal and written communication skills in bilingual (Mandarin and English).

• Experienced with equivalent test, process engineering, failure investigations, root cause analysis, measurement system analysis and automated assembly equipment is preferred.