Filling 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.

&&&PSQIT&

.60

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 Site Tianjin 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.

. Filling Isolator experiences is a plus.

Job content

Key areas of responsibility :

Maintenance engineer is engineering/operational 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 :

. 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

. SRV/Science- and Risk-based validation

. Maintenance the compliance between authority and NN requirement, also between the global standard and local SOPs. //

. Well prepare for audit in order to obtain high rating in NN internal audit and pass all inspection from authorities. Be the owner of internal or external audit finding.

NN

. Handle critical NCs/ICs/CCs fast with high quality by finding root cause and no comments during audit. NC/IC/CC

. Write critical CR and complete change on time. CR

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

. Write process and validation related documents with high quality, including PSE, VSS, VSR, APR, QMR, etc. PSE, VSS, VSR, APR, QMR

. Monitor the process trending.

. Lead and drive process optimization and improvement.

o Lead and coach improvement activities, improvement of standards within assigned process.

o Lead and coach improvement activities, improvement of standards within assigned process.

o Drive event response activities using SPS method, establishing cause and effect relationships that determine root causes. Leverage solution, best practices and benefits to process group through business case.

o Ensure anchoring of process improvement projects.

o Be responsible for ensuring that local standards are translated in accordance with DFP standard. DFP

. Train the trainer in production support team.

. Ensure daily support and sparring to production units and support units within the process area including:

o Ensure that efficient process KPIs are defined and followed up upon.

o Drive problem solving/event response to local problems and comprehensive NCs. NC

o Identify improvement opportunities and implement locally with documented benefit and drive local improvement projects.

o Own local standards. Be responsible for developing and maintaining local procedures and standards within the process, including local JTP's and training material.

o When standards are changed ensure that relevant training documents are updated and initiate training of relevant employees by informing LoB about new standard.

o Coach or ensure SOPs and standards within the process are effective by evaluating how they are used and work in praxis through PC. SOP

o Ensure compliance to external and internal regulations.

o Responsible for presenting process during inspection and audit.

o Be on point of entry to the process regarding solution.

. Participate in validation, technology transfer and process improvement:

o Ensure the validation and verification of process, machine and equipment.

o Be responsible for critical event response and NC handling during validation.NC

o Review and approve validation document and share best practices with relevant stakeholders.

o Escalate problems according to escalate procedure.

o Be aseptic behaviour owner in process department by leading smoke study.

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

. The position needs oversea travel under business need

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.