Louise Engler
Senior Validation Engineer at Confirm A/S- Claim this Profile
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German -
Topline Score
Bio
Credentials
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Dataintegritet
Confirm A/SNov, 2022- Nov, 2024 -
S88 Introduktion
Confirm A/SNov, 2022- Nov, 2024 -
Introduktion til GAMP5
Confirm A/SDec, 2021- Nov, 2024
Experience
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Confirm - Automation & Validation
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Validation Engineer
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Dec 2021 - Present
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NNE
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Denmark
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Engineering Services
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700 & Above Employee
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Qualification and Validation Engineer
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Jan 2017 - Dec 2021
Department of Mechanical, Instrumentation and Validation.I have experience in qualification and validation from design phase to production phase both in documents and performing of tests. Further more I have experience as project lead, with coordination, flow optimization and work with paperless qualification.
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Junior Project Quality Engineer
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Jul 2016 - Jan 2017
Quality and ValidationDepartment of Project Quality Execution Worked on the Novo Nordisk ED2 green field project, first as DQ Lead and then as coordinator and flow maker of the upstream vendor FAT's on site.
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Biogen
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United States
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Biotechnology Research
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700 & Above Employee
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Project associate
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Oct 2012 - Jul 2016
Worked in Purification Project Team, I supported Large Scale Manufacturing in trouble-shooting, Major and minor Projects and support tasks. My primary tasks included: - Validation, testing and Coordination of P2 Project(Green field) - Ordering, registration, establishment and trouble-shooting of analytical instruments - New hire training, including training in analytical equipment, human performance and gowning - Deviations and CAPA’s - Write and update SOP’s and work instructions - Perform EM sampling deltaV WFI/WPU - Review documantation, Control and coordinate change-overs - Ad hoch tasks to ensure and support the production Show less
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Novo Nordisk
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Denmark
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Pharmaceutical Manufacturing
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700 & Above Employee
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Laboratory Technician Trainee
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Aug 2011 - Sep 2012
Worked in the Raw Materials Analysis department. Worked in the Raw Materials Analysis department.
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Rigshospitalet
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Hospitals and Health Care
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700 & Above Employee
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Student Worker
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Jul 2010 - Aug 2012
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BASF
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Germany
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Chemical Manufacturing
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700 & Above Employee
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Laboratory Technician
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Dec 2009 - Jul 2010
Worked in the Inhalation toxicology department. Worked in the Inhalation toxicology department.
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University of Heidelberg
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Research Services
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700 & Above Employee
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Laboratory Technician
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Apr 2009 - Dec 2009
Microbiology, parasitology and pathalogy control of SPF animals. Microbiology, parasitology and pathalogy control of SPF animals.
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Education
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Metropol Proffessions Højskole
Laboratory Technician, Clinical/Medical Laboratory Technician -
KVUC
Chemistry, Biology, Math and German as singulary subjects, Chemistry