Jeppe Schmidt

Senior Validation Engineer at Confirm A/S
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Contact Information
us****@****om
(386) 825-5501
Location
Næstved, Zealand, Denmark, DK
Languages
  • Dansk Native or bilingual proficiency
  • English Full professional proficiency
  • Tysk Limited working proficiency
  • Norsk Full professional proficiency
Skills

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Credentials

  • S88 Introduktion
    Confirm A/S
    Nov, 2022
    - Oct, 2024
  • GxP data integrity What you don't know may make you non-compliant (Webinar)
    Vaisala
    Sep, 2022
    - Oct, 2024
  • Mannaz Projektlederuddannelse certifikat
    Mannaz | Kurser, uddannelser og konsulentydelser
    Jun, 2022
    - Oct, 2024
  • Projektledelse 4
    Mannaz | Kurser, uddannelser og konsulentydelser
    Jun, 2022
    - Oct, 2024
  • Speakerteknikker og showmanship med publikumsinteraktion (3 dage)
    Jerker Fahlström
    May, 2022
    - Oct, 2024
  • Projektledelse 3
    Mannaz | Kurser, uddannelser og konsulentydelser
    Mar, 2022
    - Oct, 2024
  • Projektledelse 2
    Mannaz | Kurser, uddannelser og konsulentydelser
    Nov, 2021
    - Oct, 2024
  • Projektledelse 1
    Mannaz | Kurser, uddannelser og konsulentydelser
    Aug, 2021
    - Oct, 2024
  • GMP - Brushup 2021
    Pharmakon
    Mar, 2021
    - Oct, 2024
  • GAMP5
    Confirm A/S
    Mar, 2020
    - Oct, 2024
  • Dataintegritet
    Confirm A/S
    May, 2019
    - Oct, 2024
  • Thermal validation
    Confirm A/S
    Jan, 2019
    - Oct, 2024

Experience

  • Confirm A/S
    • Colombia
    • Financial Services
    • Senior Validation Engineer
      • Jan 2021 - Present

      Writing and reviewing validation documents such as DS, FS, IFA, URS, CIL, test plans and protocols for IQ, OQ and PQ.Software validation on new and old production equipment (SW cat 3-5)SerialisationWorking for customers under ISO 13485 and ISO 9001Validation according to GAMP5, software validation (including CFR 21 Part 11 and Eudralex Annex 11)Working with Agile and Lean Qualification

    • Instructor and Course Lead
      • May 2021 - Present

      Managing the course activities in Confirm-Development of new courses and keeping existing material updated-Customer contact and tender offers-LinkedIn updates and marketing materialTeaching courses based on the ISPE guides-Data Integrity-GAMP5-GAMP5 for suppliers-GMP

    • Validation engineer
      • Mar 2019 - Jan 2021

      Writing and reviewing validation documents such as DS, FS, IFA, URS, CIL, test plans and protocols for IQ, OQ and PQ.Software validation on new and old production equipmentSerialisationWorking for costumers under ISO 13485 and ISO 9001Validation according to GAMP5, software validation (including CFR 21 Part 11 and Eudralex Annex 11)Working with Agile and Lean Qualification

  • Middelaldercentret
    • Denmark
    • Museums, Historical Sites, and Zoos
    • 1 - 100 Employee
    • Guide and speaker (freelance in weekends etc.)
      • May 2013 - Present

      Giving guided tours in the medieval town. Speaking at jousts and weapon demonstrations for up to around 1000 guests in both Danish and English. Furthermore I have presented displays with birds of prey with international falconers.Developed new shows in collaboration with the regular staff telling about both fencing and executioners

    • Trainee as assistant area manager
      • Aug 2015 - Sep 2015

      Responsible for the volunteers and delegation of tasks among employees and volunteers.Planning and organising events.Filling in with very short notice when needed to give guided tours, speaking events in both Danish and English.

  • Steelco Group
    • Italy
    • Machinery Manufacturing
    • 200 - 300 Employee
    • Project manager
      • May 2018 - Jan 2019

      Managing validation projects of new washer disinfector equipment for the pharma industry, hospitals and similar health care facilities in Denmark. Working within ISO 15883 Coordinating planning, time schedules and installations on several projects and customers simultaneously. Coordinating and keeping contact between the production facility in Italy and customers in Denmark. Planning and executing installation from FAT to IQ/OQ and PQ. Producing validation protocols, reports and similar documents. Show less

  • Novo Nordisk
    • Denmark
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Validation support engineer
      • Jan 2016 - Apr 2018

      Validation support within Global Serialisation Programme (GSP). Validating packaging lines in Biopharm in a GMP regulated environment on several Novo Nordisk Sites in Denmark. Software validation of the new serialisation software according to 21 CFR Part 11. Perfoming design qualification, planning, conducting tests and writing protocols and reports for FAT, SAT, IQ/OQ. Experienced user of eTIMS (eletronic validation software). Project manager on smaller validation projects. Validation support within Global Serialisation Programme (GSP). Validating packaging lines in Biopharm in a GMP regulated environment on several Novo Nordisk Sites in Denmark. Software validation of the new serialisation software according to 21 CFR Part 11. Perfoming design qualification, planning, conducting tests and writing protocols and reports for FAT, SAT, IQ/OQ. Experienced user of eTIMS (eletronic validation software). Project manager on smaller validation projects.

  • Gas2Green
    • Industrial Machinery Manufacturing
    • 1 - 100 Employee
    • Chemical engineer
      • Sep 2015 - Oct 2015

      Consultant within chemical engineering for startup company that has found a way to convert harmfull scrubber wastewater into electricity. I provided knowledge about electrolysis and reactions in acedic and caustic environments. Consultant within chemical engineering for startup company that has found a way to convert harmfull scrubber wastewater into electricity. I provided knowledge about electrolysis and reactions in acedic and caustic environments.

  • DTU ScienceShow
    • Denmark
    • Professional Training and Coaching
    • 1 - 100 Employee
    • Board member and Scientific Performer/Communicator
      • Oct 2010 - Mar 2015

      Promoting natural sciences for schools and high school students by means of entertaining lectures with spectacular demonstration experiments to lure new knowledge into the audience's head.Member of the board and responsible for hiring and training of new employees.

    • Teaching Assistant in inorganic chemistry
      • Sep 2014 - Dec 2014

      Teaching a class of approximately 30 first semester students in a theoretical course about inorganic chemistry.

  • Nykredit
    • Financial Services
    • 700 & Above Employee
    • Project Employee
      • Feb 2009 - Aug 2009

      Data transfer and test of a new computer system for currency transactions. Part of the daily team conducting foreign exchange trade. Data transfer and test of a new computer system for currency transactions. Part of the daily team conducting foreign exchange trade.

Education

  • Danmarks Tekniske Universitet
    M.Sc.Eng., Advanced and Applied Chemistry
    2012 - 2015
  • Norges teknisk-naturvitenskapelige universitet (NTNU)
    Exchange student, Chemical Engineering
    2014 - 2014
  • Danmarks Tekniske Universitet
    B.Sc.Eng., Chemical Engineering, Chemistry and Technology
    2009 - 2012
  • Danmarks Tekniske Universitet
    Supplementary course in mathematics from B to A level, Advanced and Applied Chemistry
    2008 - 2008

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