[ PDCP ] Component Process Validation Engineer
【Job Overview】
The Component Process Validation Engineer is responsible for defining and executing validation strategy and coordinating validation activities required to qualify the Metal/Packaging/Printing components forming process and equipment into the production environment. The successful candidate will perform validation activities that include Equipment Validation and Process Validation of an integrated manufacturing system across the entire validation lifecycle from Plan to Retire.
零件確效工程師負責執行醫療器材中金屬、印刷與包裝零件之確效，確保機台與製程可轉移至量產。合格的確效工程師將能妥善制定合適的確效計畫，確保該產品於其生命週期中能持續符合預期水準。
【Main Responsibilities】
• Construct effective validation strategy for Metal/Packaging/Printing components forming process and equipment.
• Generate and sustain Verification/Validation protocols (IQ, OQ, PQ, PV) and related technical documents to support the transfer of process/equipment into production.
• Participate in design, development, commissioning and qualification of manufacturing equipment/process with a diverse functional engineering team.
• Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.
• Assist in failure investigations and root cause analyses.
• Involve in internal and external audit.
• 針對金屬、印刷與包裝零件之製程與機台，制定科學化的確效策略並撰寫、執行相關計畫書與報告 (IQ, OQ, PQ, PV)。
• 參與機台/製程之開發，並積極與各部門合作，提供確效面向中技術與品質上的評估。
• 針對確效中異常狀況進行根因調查。
• 參與內部與外部單位稽核。
【Required Criteria】
• Bachelor’s degree in Mechanical Engineering, Material Science, Biomedical Engineering, or related field.
• Good at English verbal communication, writing and reading (TOEIC 600 or above).
• Good at Mandarin communication and reading.
• Skills of experimental design, problem solving and data analysis.
• Strong communication and project management skills
• Basic statistical knowledge (e.g. concept of k value/Cpk, normality distribution)
• 工程相關學歷，如機械系、材料系、醫工系等
• 可使用英文溝通並善於英文閱讀與書寫 (多益600分或以上)
• 具備實驗規劃、問題解析及數據分析能力
• 善於溝通及任務時程掌控
【Preferred Qualifications】
• 2+ years engineering experience in medical device, pharma industry, technology industry, or related fields.
• Knowledge of GMP, ISO, FDA rules and regulatory requirements (e.g. ISO 13485, 21 CFR Part 11, 21 CFR 820 and FDA GMPs).
• Experience of developing manufacturing equipment or metal/printing/packaging component forming process.
• 兩年以上醫材、醫藥、科技業或相關領域業界經驗
• 熟悉GMP、ISO、FDA相關條例與法規 (如 ISO 13485, 21 CFR Part 11, 21 CFR 820 and FDA GMPs)
• 具有機台開發或鐵件/印刷/包裝零件製程開發經驗