高级工程师
Senior Engineer
### **职业类别**
科学
### **职位描述**
向外部工艺工程高级经理汇报，该职位将位于安进邓莱里（Co. Dublin），作为全球工艺开发组织的一部分。该职位需要候选人远程支持欧洲各地无菌药品生产合同制造站点的生产。
工作任务可能包括新产品引入、生命周期变更和持续的商业生产支持。候选人将支持多种产品形式（如药筒、注射器、冻干和液体安瓿瓶）；以及多种产品类型（包括单克隆抗体、治疗性蛋白、小分子和更新型的模式），在多个制造站点进行操作。
需要前往欧洲的合同制造合作伙伴站点进行一些国际旅行。成功候选人将：
- 作为药品技术专家，在所有加工阶段（从原料药解冻、配方、灌装、冻干、检验和安瓿瓶、注射器及设备运输）出现的无菌药品生产问题时提供领导力和解决方案，涵盖新产品引入（NPI）或后NPI阶段。
- 与合同制造合作伙伴、全球运营、外部供应商质量及药品工艺团队建立良好的业务关系。
- 展示通过跨站点团队进行领导的能力，通常通过设定议程和识别潜在问题来实现。
- 在特定领域（如无菌工艺、工艺表征、技术转移和工艺验证）为商业药品生产提供工艺开发专业知识。
- 解决药品生产工艺技术和设备方面的问题。
- 识别并实施当前和新无菌操作的运营机会。
- 为商业药品生产运营和外部供应商质量提供技术评估，处理NC/CAPA。
- 前往合同制造站点以支持关键生产里程碑并建立关系。
**基本要求：**
- 熟悉cGMP及其他全球监管要求。
- 具备出色的解决问题能力。
- 出色的口头和书面沟通技巧。
- 科学、工程或相关质量领域的学士学位，并在类似岗位有5年工作经验
查看英文原文
### **Career Category**
Scientific
### **Job Description**
Reporting to the Senior Manager of External Process Engineering, this role will be based out of Amgen Dun Laoghaire, Co. Dublin as part of the global Process Development organization. This role will require the candidate to remotely support manufacturing at various aseptic drug product contract manufacturing sites around Europe.
Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production. The candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials); and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities), across multiple manufacturing sites.
Some International travel will be required to visit contract manufacturing partner sites in Europe. The successful candidate will:
- Act as a drug product technical expert, to provide leadership and solutions when troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices, for parenteral products through the new product introduction (NPI) or post-NPI phases.
- Build excellent business relationships with contract manufacturing partners, Global Operations, External Supplier Quality, and drug product process teams.
- Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues
- Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterization, technology transfer, and process validation.
- Troubleshoot issues with drug product processing technologies and equipment.
- Identify and implement operational opportunities for current and new sterile operations.
- Support commercial drug product manufacturing operations and external supplier quality with technical evaluation of NC/CAPA.
- Visit contract manufacturing sites to support key production milestones and build relationships.
**Basic Qualifications:**
- Knowledge of cGMP’s and other worldwide regulatory requirements.
- Proven problem-solving ability.
- Excellent oral and written communications skills.
- A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master’s degree & 3 years' directly related experience OR Associate’s degree & 10 years of directly related experience.
- Full clean driving license required to facilitate travel.
**Preferred Qualifications and Experience:**
- Language skills such as Italian or German would be an advantage.
- Masters or PhD in Science or Engineering.
- 5+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Process Validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, lyophilisation, and/or inspection processes.
- Knowledge of protein biochemistry with regard to chemical and physical stability.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of quality and regulatory systems, drug product manufacturing and process validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
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**Salary Range**
70,408.90 EUR - 95,259.10 EUR