设备工程师

Posted 16 Nov 2022

Wuxi, Jiangsu - China

Req Id 257298

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 352 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:
1.    Review and confirm the URS (together with production/process)
2.    Follow up and expedite the equipment manufacturing progress
3.    Ensure equipment vendor’s FAT protocol meet our requirements, attend FATs, and issue release notes / sign off of the FAT prior to delivery.
4.    Acquire necessary know-how and operations of process equipment through giving site training, or visual training. To be the local expert for those critical equipment in bag making lines.
5.    Able to support the SAT/IOQ, and drive for problem solving.
6.    Ensure the behavior in accordance with compliance and EHS, complete the training on time.
7.    Perform routine equipment safety inspection and machinery optimization during daily site survey.
8.    Recommends technical solutions for improving EHS and realize the recommendations after approval into a technical solution.
9.    Support the accident/incident reporting and investigation.
10.    Take over the lead investigation for SU equipment deviations and CAPAs
11.    Support the Qualification / Validation activity including start-up for new or maintained equipment/new products
12.    Check and manage to ensure no production interruption caused by maintenance team.
13.    Be responsible for installation and acceptance of new equipment to ensure the compliance with the requirement of the local government and Merck standard. 
14.    Ensure the good documentation practice, tidy up and manage the technical drawings, manual, documents, change management, keep the updated drawings and create, revise SOPs to comply with GMP requirement. 
15.    Spare parts control with the daily requisition issue and budget including the local manufacture to replace the imported spare parts partly.
16.    According to the production plan of production department, make maintenance plan, estimate working hours and contact production team to arrange personnel.
17.    Communicate with production team to make sure equipment and facility meet their requirements. 
18.    Training technician and support troubleshooting.
19.    Analysis data (MTTR, MTBF, cost, labor-hour etc.) to improve PM and CM. Modify the process equipment to improve the equipment reliability and safety.
20.    Pursue for the optimization of equipment function and continue improvement for equipment and system.
21.    Comply with the company's safety and quality regulations and participate in the safety and quality training organized by the company
22.    Other works assigned by department head.

 

Who you are:
•    Education: 
Bachelor or above degree in Mechanical engineering or related major.
•    Working Experience: 
1.    At least 7 years production equipment maintenance/management experience with the pharmaceutical equipment or Biopharmaceutical process line.
2.    Knowledge of occupational safety and GMP
3.    Experience in non-standard equipment URS creation & FAT &SAT execution& Installation & Qualification.
4.    PE bag making industry experience is plus.

•    Technical & Professional Knowledge: 
1.    Fluent English
2.    Strong coordination, analytical, judgment, communication and problem-solving skill
3.    Knowledge of GMP
4.    High troubleshooting ability
5.    Good customer focus and teamwork coordination

6.    Experienced user of Office software as well as data bases

 

HR: 95989

Functional Area: Engineering & Skilled Trade
 


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!


Careers during Covid-19

Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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