高级包装工程师
Senior Packaging Engineer
职位描述
一个绝佳的机会正在寻找一名**高级包装工程师**。
该职位是外部制造与网络设备团队的重要组成部分，负责将产品和技术转移至合同制造组织（CMO）。该职位将与外部包装合作伙伴（即ExM领域的合同制造组织）进行互动。个人将与其他ExM职能（技术、质量、运营、供应链、采购）及包装社区内的技术专家紧密合作。个人将利用其科学、技术和商业专业知识，支持团队解决复杂的包装问题，优化流程并确保合规性，专注于开发和执行小分子和大分子资产的一次性和二次性包装组件，组装医疗设备组合产品，设计包装设备，并确保包装工艺控制和效率。该职位需要具备强大的技术能力来支持和改进业务、技术和合规流程，并在高影响力的跨职能团队中协作。
- 支持小分子和大分子项目、医疗器械和组合产品的技术转移、确认、验证、流程改进和变更控制。
- 确保包装和组装流程的合规性，包括项目管理、场地准备和执行卓越。
- 自主协调、沟通和监督与外部包装合作伙伴的技术事务。
- 为质量和供应调查提供技术支持，并共同领导关于包装流程、设备和组件的讨论，以识别根本原因并制定纠正和预防措施。
- 支持对外部包装合作伙伴的技术评估，并创建全面的评估以选择合作伙伴。
- 参与与外部包装合作伙伴的定期业务评审会议。
- 领导或支持包装图像和材料/组件的复杂变更。
- 支持成品包装配置的分销和温控运输/存储方法的修改确认。
**带来活力、知识和创新，完成以下工作：**
**你需要具备的技能：**
要在这个职位上表现出色，你很可能具备：
- 至少5年的医疗器械或组合产品工程和包装相关经验
查看英文原文
Job Description
A fantastic opportunity has arisen for a **Senior Packaging Engineer.**
This role serves as an essential part of the External Manufacturing & Network Equipment team, overseeing product and technology transfers to Contract Manufacturing Organizations (CMOs). The role will interact with external packaging partners, which are Contract Manufacturing Organizations in the ExM space. The individual will work closely with other ExM functions (Technology, Quality, Operations, Supply Chain, Procurement) and technology experts within the greater packaging community. The individual will leverage their scientific, technical, and business expertise to support teams in solving complex packaging issues, optimizing processes, and ensuring compliance, focusing on developing and executing primary and secondary packaging components for Small and Large Molecule assets, assembling Medical Device Combination Products, designing packaging equipment, and ensuring packaging process control and efficiency. The position requires strong technical skills in supporting and improving business, technical, and compliance processes, and collaborating within high-impact cross-functional teams.
- Support technology transfers, qualifications, validations, process enhancements, and change controls for Small and Large Molecule projects, medical devices, and combination products.
- Ensure compliant packaging and assembly process transfer, project management, site readiness, and execution excellence.
- Coordinate, communicate, and oversee technical matters with external packaging partners autonomously.
- Provide technical support for quality and supply investigations, and co-lead discussions on packaging processes, equipment, and components to identify root causes and develop corrective and preventative actions.
- Support technical evaluations of external packaging partners and create thorough assessments for partner selection.
- Participate in periodic Business Review Meetings with external packaging partners.
- Lead or support complex changes of packaging images and materials/components.
- Support the qualification of modifications to distribution and thermal transport/storage methods for finished packaging configurations.
**Bring energy, knowledge, innovation to carry out the following:**
**What skills you will need:**
In order toexcel in this role, you will more than likely have:
- Minimum of 5 years’ experience in medical device or combination product engineering and pharmaceutical field, with practical knowledge in packaging operations, materials, and processes.
- Experience in capital packaging equipment projects, including technology transfers, designing packaging lines, equipment installation and validation, and troubleshooting.
- Experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.
- Proficiency in project management from conception to closeout, with strong GMP and quality systems expertise.
- Solid understanding of scientific or technical concepts for routine and complex tasks, with advanced practical knowledge of applicable techniques.
- Experience with manufacturing change control compliance systems like Veeva and quantitative decision tools for risk management.
- Demonstrated leadership qualities, inclusive practices, and ability to work in a diverse, cross-functional team.
- Familiarity with the regulatory standards of key pharmaceutical markets, such as USFDA, cGMPs and EMA guidelines.
- Demonstrate commitment to continuous improvement by proactively adopting new strategies, drawing insights from experiences, and making informed decisions regarding risk-taking. Regard setbacks as valuable learning opportunities rather than impediments.
- Adopt a critical mindset in decision-making to ensure thorough analysis while considering potential impacts on key stakeholders.
- Strong analytical and decision-making abilities, combined with outstanding oral and written communication skills.
- Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringinginclusive, talented, and committed people together.
Pleasedon'thesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
**So, if you are ready to:**
Invent solutions to meet unmet healthcare needs,**please apply today.**
**Required Skills:**
Change Control Processes, Driving Continuous Improvement, Engineering Standards, Packaging Engineering, Packaging Equipment, Packaging Innovation, Packaging Management, Packaging Operations, Packaging Optimization, Pharmaceutical Packaging, Sealing Machines
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
**VISA Sponsorship:**
**Travel Requirements:**
**Flexible Work Arrangements:**
Remote
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
10/1/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**