Maintenance Engineer II

Job description

Maintenance Engineerll Introduction about us At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work: - We Care for our patients, each other, and our communities - We Connect across teams and borders to deliver excellence together - We Commit to doing things the right way—growing with purpose and leading kidney care with integrity and innovation Information about Engineering Department The Buzen Plant of Fresenius Medical Care is a key manufacturing site in Japan, producing high-quality medical devices and dialysis-related products. Operating under strict GMP and QMS standards, the plant ensures product safety, reliability, and compliance while supporting both domestic and global healthcare needs. The Engineering Department plays a vital role in maintaining stable and efficient operations by managing production equipment, utilities, and infrastructure, and by driving maintenance strategies, equipment improvements, and safety compliance. Engineering collaborates closely with production, quality, and other cross-functional teams, while also coordinating with external vendors and the Inukai Plant to ensure consistency and operational excellence across sites. Summary about role As a Maintenance Engineer II , you will be responsible for maintaining, managing, and improving manufacturing equipment, utility systems, and facility infrastructure. Through routine maintenance, troubleshooting, and indirect engineering tasks such as spare parts management, SOP development, and validation support, you will contribute to stable operations, cost reduction, and improved safety and efficiency. Key Responsibilities 1. Equipment Maintenance & Troubleshooting Perform daily and periodic maintenance of manufacturing, utility, and facility equipment Detect, analyze, and respond to equipment malfunctions Support decision-making and escalation for equipment issues 2. Engineering Support Activities Manage spare parts and consumables Develop and maintain SOPs Support validation planning and execution Manage measuring instruments and calibration 3. Manufacturing Equipment Support Maintain and troubleshoot PD and HD manufacturing equipment Ensure stable equipment operation to support production 4. Continuous Improvement Promote improvements in cost reduction, trouble reduction, and work efficiency Enhance workplace safety and operational processes 5. Compliance & Safety Follow GMP/QMS and safety regulations Ensure safe and compliant execution of all maintenance activities Your Profile Education & Experience High school diploma or higher (technical/engineering background preferred) Experience in manufacturing equipment operation and maintenance Experience in safety practices (KY activities, hazard prevention) Basic knowledge of pharmaceutical or medical device manufacturing Technical Skills Basic knowledge of electrical and/or mechanical engineering Experience with equipment maintenance and troubleshooting Familiarity with GMP/QMS environments Proficiency in Microsoft Office (Word, Excel, etc.) Competencies Ability to follow procedures and work accurately based on SOPs Strong attention to detail and problem detection skills Teamwork and collaboration across departments Proactive and calm response to equipment issues Continuous improvement mindset Language Skills Japanese: Fluent (reading, writing, communication) English: Basic to intermediate level for work purposes Our Offer There is a lot you can discover at Fresenius Medical Care, regardless of your field of expertise or level of experience—all dedicated to your professional journey. Work in a global healthcare manufacturing environment Gain hands-on experience in advanced production and utility systems Contribute to high-quality and safe manufacturing operations Develop your technical and professional skills through on-the-job training Collaborate with cross-functional teams in a dynamic environment 会社紹介（Introduction about us） フレゼニウス メディカル ケアは、腎臓ケアのグローバルリーダーとして、慢性腎臓病患者の生活向上に貢献しています。当社は、医療のあらゆるプロセスにおいて高品質で革新的な製品・サービスを提供することを使命としています。 エンジニアリング部門について フレゼニウス メディカル ケア豊前工場は、日本における主要な製造拠点であり、高品質な医療機器および透析関連製品を製造しています。厳格なGMPおよびQMS基準のもとで運営されており、製品の安全性・信頼性・コンプライアンスを確保しつつ、国内およびグローバルの医療ニーズを支えています。 エンジニアリング部門は、生産設備、ユーティリティ、およびインフラの管理を通じて、安定かつ効率的な操業の維持において重要な役割を担っています。また、保全戦略の推進、設備改善、安全・コンプライアンスの確保に取り組んでいます。さらに、生産・品質などの関連部門と密接に連携するとともに、外部業者や犬飼工場とも協働し、拠点間の整合性およびオペレーショナルエクセレンスの実現に貢献しています。 職務概要 本ポジションは、製造設備およびユーティリティの安定稼働と継続的改善を担います。設備保全・改善活動やエネルギー管理を通じて、生産の信頼性向上、コスト最適化、GMP/QMS遵守に貢献します。 主な業務内容 1. 設備保全と信頼性向上 ・設備保全計画の立案・実行 ・予防保全の実施 ・トラブル対応 2. 改善活動 ・設備改善・更新の推進 ・不具合の原因解析と再発防止 3. 品質・コンプライアンス ・GMP/QMS遵守 ・SOPに基づく業務遂行 4. 関係部門との連携 ・社内部門や外部業者との調整 5. エネルギー管理 ・エネルギー使用の最適化 6. 人材育成 ・後輩の指導・育成 応募資格 ・工学系学位または同等の知識 ・製造業でのエンジニア経験3年以上 ・GMP/QMSの知識 ・問題解決力、コミュニケーション力 ・日本語：ビジネスレベル（必須） ・英語：基礎〜ビジネスレベル 当社で働く魅力 ・グローバル企業でのキャリア形成 ・高品質な医療製品に貢献 ・成長機会と研修制度 ・チームワーク重視の職場