Downstream Production Engineer

Posted 06 Apr 2022

Shanghai, Shanghai - China

Req Id 244945

Details

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 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. Position Information

Title

Downstream Production Engineer

Department

E2E APAC

Report to

Downstream Production Associate Manager

Location

Shanghai

 

  1. Major Responsibility

 

Downstream production

  • Proceed downstream production according to project protocol and SOP
  • Record and behavior follow the compliance with laws, GMP regulations and SOPs
  • Draft and review SOPs, batch records and logbooks for downstream production
  • Fill in and summarize production data and QC data in time.
  • Daily, weekly and monthly clean and disinfection of facility and equipment
  • Assist quality team to deal with the deviation, change and CAPA in DSP production
  • Carry out investigations in relation to the domain concerned and participate in problem resolutions
  • Participate in the drafting of the batch evaluation documents (campaign reports release reports, etc.)
  • Assist in DSP buffer preparing work
  • Train and/or organize the training of the staff of the relevant team with support from the development department and the compliance team
  • Be able to receive appropriate overtime and night shifts

 

Project

  • Reasonable arrangement the timeline of project, delivery process on time
  • Participate in the transfer of internal and external processes (from development to production)
  • Summarize project data, drafting and review project protocols and reports
  • Document and present results in the form of detailed reports in English to internal clients (Department, site, group) and external

 

Team work 

  • Follow up material and consumable inventory to meet the projects requirement and quality, review the logbook of in/out bound
  • Ensure assigned equipment validation (IQ/OQ/PQ if necessary), calibration and maintenance work are done and documented as scheduled.
  • Proposes solutions to the problems of equipment and technical problems and to ensure coordination and follow-up with technical services and external suppliers if necessary
  • Cooperate to prepare and update common area SOPs and other documentation as needed to support client projects and internal activities
  • Support and actively participate in continuous improvement initiatives
  • Ensure the work area is safe and clean. Keep up to date with Health and Safety regulations,
  • Other works assigned by manager

 

 

Who you are:

  1. Qualification

 

Education

  • Bachelor of Science Degree or above
  • Major in Biochemistry, Chemical Engineering, Biotechnology, Bioengineering, Pharmacy or equivalent

 

Experience

  • Deeply understand downstream process product and equipment
  • At least 2 years GMP production in downstream work experience.
  • Good sense of scale up and scale down, including the theory, material calculation and preparation
  • Team spirit and respectful behavior
  • Strong sense of responsibility and professionalism
  • Ability to learn, then apply the appropriate safety measures to work in a steam environment, pressure and in contact with chemicals.
  • Theoretical and practical knowledge in the field concerned.
  • Experience in environment controlled and/or subject to GMP.
  • Familiar with Microsoft Office software, especially Word, Excel and Powerpoint.

Language Skill

  • Fluent English reading and writing
  • Fluent English Speaking is a plus

 

HR: 89829

Functional Area: Research & Development


 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

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