PDAP - Assembly Process Validation Engineer

About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

As an Assembly Process Validation Engineer, you will be 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。

Main Responsibilities

• 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.

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• 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。

Minimum Qualifications

• 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).

Preferred Qualifications

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

We Offer :

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where 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.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy. 

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.