Downstream Production Engineer

Title

Downstream Production Engineer

Department

E2E APAC

Report to

Downstream Production Associate Manager

Location

Shanghai

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

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