WS engineer-?????

201920202022Kincentric

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

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Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and build all major fill & finish expansion projects across Product Supply, Quality & IT to serve the needs of millions of patients. We do it by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, designing facilities we will still be proud of 20 years from now.

As a part of that, Fill & Finish Expansion Tianjin project is located at No. 60, Muning Road in TEDA, adjacent to the current manufacturing site. Here, you will be working with multiple sites and cultures across the world to join efforts to drive changes and improve the lives of patients with diabetes and other chronic diseases.

Apply now if you wish to be a part of this exciting global program in Novo Nordisk!

Qualifications (minimum requirements)

Education Background:

. Bachelor Degree and above in mechanical engineering, industrial engineering, electrical engineering, chemistry, pharmacy, bioscience, computer science or similar education background.

. Education/training of cGMP is preferable. cGMP

. Fluent in written and reading English.

Professional Experience:

. Minim 7 years of relevant working experience. Thereinto minim 5 years of production experience in aseptic process of cGMP regulated pharmaceutical industry or in life science industry. 4-62-5cGMP

. Knowledge and experience on cGMP or GMP manufacturing process equipment management/maintenance. cGMPGMP/

. Experience of working in cross function team environment.

. Strong documentation experience.

Job content

Key areas of responsibility :

WS Maintenance engineer is engineering responsible during project execution, ensuring SRV/ Science- and Risk-based validation implementation, product quality and compliance, prepare for audit readiness and execution, validation and revalidation. The position plays an important role in cGEP and cGMP, and continuously improving standards in operation process.

Main Job Tasks :

SRV/Science- and Risk-based validation

. Responsible for Design Review, FAT/factory acceptance testing, SAT/Site Acceptance Testing, Commissioning, IV/Installation Verification, OV/Operational Verification and improving OEE in ramp-up

OEE

. Review and approve design and engineering documents (including PID, FS, ES, Wiring Diagram, CCA etc.) to ensure correct equipment construction and in compliance with URS.

PID, FS, ES, ., CCAURS

. Design, plan, lead and carry out initial validation, establish validation state in compliance with regulatory and NN requirements on time.

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. Write validation related documents with high quality, including VPL, FAT/SAT, IV/OV/PfV plan/report, SE, VSS, TMX, etc.

VPL, FAT/SAT, IV/OV/PfV plan/report, SE, VSS, TMX, etc.

. Plan and carry out re-validation with shortest stop for production and write high quality validation documentation.

. Drive Investigation of Validation Deviation, minimize impact on validation activity and make corrective/preventive actions

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Maintenance and Continue Improvement Related task:

. Take the responsibility of machine owner. Implement corrective maintenance and preventive maintenance according to SOP. Ensure all machines troubleshooting timely. Ensure machines running well with high performance and low variation. Ensure safety when working with machine. SOP

. Ensure stability batches, media fill, PV batches and production batches are executed according to milestones. Clear communicate with production team to make sure production will not be impacted.

. Establish and improve equipment maintenance standards, processes/procedures and system to meet GMP requirement. GMP

. Handle DV, investigate the root cause and cooperate with production team and process team together try to close it by cLEAN tools systematically.

. Cooperate with production, process and supplier to continuous improve OEE, reduce down time, reduce scrap rate, minimize production impact caused by machine. Handle CR (change) for machine improvement and optimization.

OEE

. Participate in new project and new machine introduction at the early beginning of project of new machine. Participate in design review and test review so that some error can be found earlier. Execute test and validation.

. Ensure all maintenance activities are done according to SOP, passing all internal and external audits without any findings about SOP compliance. SOP

. Make sure all maintenance activities are in compliance with safety, production or quality requirements or standard.

Other individual assignments :

. Incorporate Novo Nordisk Way (NNW) into daily way of working NNW

. Other work assigned by line manager.

. Keep line manager accurately informed of work status as well as any problems

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.