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Career
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Janne Hamborg Nielsen

Process Engineering Specialist

 Good Manufacturing Practice | Personal | Technology

Summary

Janne has extensive experience from 21 years of working in Novo Nordisk A/S at different plants. Latest she has been working at a cultivation and purification plant with the responsibility for clean utility (water, clean steam and gasses) incl. reporting. She has a wide range of competences working with daily production of water and steam, changes, deviations.

Part of her experience comes from working as utility-supporter in a cross-functional team with responsibility for EM, clean utility and distillation of Ethanol. Furthermore, she has project-experience as a user on major projects and has independently executed smaller projects.

A few of Jannes wide range of competencies:

  • Deviations and systematic problem-solving, with a high-quality mindset, to find the right root cause and mitigating actions to avoid reoccurrences.
  • Change request, on smaller and bigger changes, including impact-assessment and risk evaluation.
  • Operation Responsible
  • Requirement setting for equipment on a risk-based approach.
  • Verification steps as DQ, OV, IV and PFV
  • SME on clean utility
  • HVAC

Special Competences

  • GMP: Hands-on experience making batch-records, SOP’s and other quality paperwork, trend-reporting. Deviations, systematic problem-solving and Change request. Protocols for validation/verification and test.
  • Technology: Experienced in working with a wide range of processes such as HVAC, clean steam, nitrogen, process air, CO2, O2, N2, WFI, Process water, purified water, distillation of ethanol and sampling.
  • Personal: Structured and good at creating and keeping overview, Responsible and with a high quality mindset, solution oriented, good mood and a team player.

Project Experience

  • Removal of time delay for startup conditions for WFI production Change request and OR for the program-change on time-delay.Novo Nordisk A/S, Denmark – 2024
  • Annex 1 signal “True point of use”CR-case responsible, DQ and participation in planning of project implementationNovo Nordisk A/S, Denmark – 2024
  • Extension of WFI loopPrimary user and Operational Responsible, for requirement setting, Design Qualification and execution of PFV fase 2 on WFI loop.Novo Nordisk A/S, Denmark – 2022
  • Implementation of new sample point WFIPrimary user and Operational Responsible, for requirement setting, Design Qualification and execution of PFV fase 2 on WFI.Novo Nordisk A/S, Denmark – 2022
  • Extend time interval between sanitation of WFIChange request responsible.Primary user and Operational Responsible, for requirement setting, Design Qualification and execution of PFV fase 2 on WFI sanitation.Novo Nordisk A/S, Denmark – 2022
  • Re-qualification of HVAC systemsOperation-Responsible for re-qualification of HVAC systems.Novo Nordisk A/S, Denmark – 2019
  • Process group responsible for clean utilityNovo Nordisk A/S, Denmark – 2016-2024
  • Change of pressure gauge on Purified Water production Validation responsible for performing IQ and OQNovo Nordisk A/S, Denmark – 2014
  • Reduction of ZA waste to M-onsu waste, and use of the waste for distillationOperational responsible for performing PFV with test, sampling and reporting.Novo Nordisk A/S, Denmark – 2014
  • New sample devices for ad hoc samples from EDI’s on purified waterOperational responsible on IV, OV and PFV. Responsible for performing PFV with test, sampling and reporting.Novo Nordisk A/S, Denmark – 2014
  • Change of pressure gauge on Purified Water Validation responsible for performing IQ and OQNovo Nordisk A/S, Denmark – 2013
  • Minimizing bleed of amount in distillations columns without compromising the quality. Operational responsible for performing PFV with test, sampling and reporting.Novo Nordisk A/S, Denmark – 2012
  • Sampling units for distillation columns.Operational responsible on IV, OV and PFV. Responsible for performing PFV with test, sampling and reporting.Novo Nordisk A/S, Denmark – 2011-2012
  • Multiple microbial count samples from WFI exceeds specification Critical case whit potential shutdown of production.Deviation and systematic problem-solving responsible.Novo Nordisk A/S, Denmark – 2022

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