制剂DP生产设备高级经理hz

/ Job Description 负责制剂工艺设备的整体管理与运维，涵盖设备引入、运行维护、技术改造及持续优化，建立高效、合规、可靠的设备管理体系，保障制剂生产稳定运行并持续提升设备可靠性与生产效率。 Responsible for overall management and operation of drug product process equipment, including equipment introduction, maintenance, technical upgrades, and continuous improvement, establishing an efficient, compliant, and reliable management system to ensure stable manufacturing and continuous improvement of equipment reliability and productivity. ________________________________________ 岗位职责 / Job Responsibilities

1. 01

   制剂工艺设备管理体系建设 建立并持续优化制剂工艺设备管理体系，确保符合GMP及质量管理体系要求。 Establish and continuously improve the management system for drug product process equipment to ensure compliance with GMP and quality management systems. 制定设备标准、操作规范及维护策略，推动设备管理标准化与数字化。 Develop equipment standards, SOPs, and maintenance strategies to drive standardization and digitalization. ________________________________________

2. 02

   设备全生命周期管理 负责制剂工艺设备全生命周期管理，包括选型、设计评审、采购、安装、调试及验证。 Manage the full lifecycle of drug product equipment, including selection, design review, procurement, installation, commissioning, and

. 组织设备维护、校准及再验证，确保设备持续处于受控状态。 Organize maintenance, calibration, and requalification activities to maintain equipment in a validated state. ________________________________________

3. 03

   制剂设备运维与可靠性提升 负责日常设备运维管理，确保生产连续稳定运行。 Manage daily equipment operation and maintenance to ensure continuous and stable production. 主导设备故障分析及根因分析，推动CAPA实施。 Lead failure investigation and root cause analysis, and drive CAPA implementation. 通过数据分析持续优化维护策略，提高设备OEE及生产效率。 Continuously optimize maintenance strategies based on data to improve equipment OEE and productivity. ________________________________________

4. 04

   工艺支持与技术优化 支持制剂工艺开发、技术转移及工艺优化活动。 Support process development, technology transfer, and process optimization activities. 参与设备调试、参数优化及性能测试，确保设备能力满足工艺要求。 Participate in equipment commissioning, parameter tuning, and performance testing to ensure process compatibility. 提升产品质量一致性及生产效率。 Enhance product quality consistency and production efficiency. ________________________________________

5. 05

   工程建设及设备改造项目管理 负责制剂工艺设备相关工程建设及改造项目的全过程管理。 Lead end-to-end management of engineering construction and retrofit projects for drug product equipment. 包括方案评估、设计评审、施工管理、调试及交付。 Cover feasibility assessment, design review, construction, commissioning, and handover. 确保项目按进度、质量及成本目标交付，并符合GMP及验证要求。 Ensure projects are delivered on schedule, within quality and cost targets, and meet GMP and qualification requirements. ________________________________________

6. 06

   自动化及系统集成支持 支持与制剂设备相关的自动化系统运行与优化。 Support operation and optimization of automation systems related to drug product equipment. 推动设备与MES/SCADA等系统集成及数据完整性管理。 Drive system integration and ensure data integrity compliance. ________________________________________

7. 07

   质量合规与审计支持 确保设备相关活动符合GMP及法规要求。 Ensure all equipment-related activities comply with GMP and regulatory requirements. 支持内外部审计，管理偏差、变更、CAPA及风险评估。 Support audits and manage deviations, change control, CAPA, and risk assessments. ________________________________________

8. 08

   团队管理与跨部门协作 建立并管理制剂工艺设备团队，提升团队技术能力与执行力。 Build and manage the drug product equipment team to enhance capability and execution. 与生产、QA、验证及工程团队协作，确保设备与工艺匹配及稳定运行。 Collaborate with Production, QA, Validation, and Engineering teams to ensure alignment. ________________________________________

9. 09

   成本与资源管理 负责设备运维预算及成本控制。 Manage O&M budget and cost control. 优化备件管理及资源配置，提高设备利用率。 Optimize spare parts and resource allocation to improve efficiency. ________________________________________ 任职要求 / Job Requirements 教育背景 / Education 本科及以上学历，制药工程、生物工程、机械或自动化相关专业。 Bachelor’s degree or above in Pharmaceutical Engineering, Bioengineering, Mechanical, or Automation-related fields. ________________________________________ 工作经验 / Experience 具备8年以上制药行业制剂设备相关经验，其中至少3年以上管理经验。 Minimum 8 years of experience in drug product equipment in the pharmaceutical industry, with at least 3 years in a leadership role. 具备制剂工艺设备管理经验，如灌装、冻干、配液、过滤等设备。 Solid experience with drug product equipment such as filling lines, lyophilizers, formulation systems, and filtration systems. 具备工程建设或设备改造项目管理经验。 Proven experience in engineering construction or retrofit project management. ________________________________________ 专业能力 / Technical Competence 熟悉制剂工艺及设备运行原理。 Familiar with drug product processes and equipment operation principles. 具备设备选型、技术评审及工程决策能力。 Strong capability in equipment selection, technical evaluation, and engineering decision-making. 具备设备可靠性及持续改进能力。 Strong capability in reliability management and continuous improvement. 熟悉GMP及审计要求。 Solid understanding of GMP and regulatory requirements. ________________________________________ 综合能力 / Leadership & Soft Skills 具备良好的领导力及跨部门协作能力。 Strong leadership and cross-functional collaboration skills. 具备数据分析能力及持续改进意识。 Strong analytical skills and continuous improvement mindset.