Simon Falkerslev Email & Phone Number
@student.dtu.dk
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Who is Simon Falkerslev? Overview
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Simon Falkerslev is listed as Visual inspection SME at FUJIFILM Diosynth Biotechnologies, a with 5508 employees, based in Copenhagen, Capital Region of Denmark, Denmark. AeroLeads shows a work email signal at student.dtu.dk and a matched LinkedIn profile for Simon Falkerslev.
Simon Falkerslev previously worked as Inspection specialist at Xellia Pharmaceuticals and Safety engineer at Banedanmark. Simon Falkerslev holds Master Of Science (Msc), Medicine And Technology from Technical University Of Denmark.
Email format at FUJIFILM Diosynth Biotechnologies
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About Simon Falkerslev
Biomedical engineer with 9 years of experience in pharmaceutical manufacturing. Specialized in the regulatory requirements within visual inspection and hands-on experience with manual, semi-automatic and fully-automatic inspection of drug products. Certified six sigma green belt with thorough understanding of applied statistics and statistical quality control. Scripting skills in Matlab, Python and SQL. Practical experience with project management and ability to complete tasks in a multi-stakeholder landscape.
Listed skills include Digital Image Processing, Visual Inspection, Data Mining, Machine Learning, and 15 others.
Simon Falkerslev's current company
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Simon Falkerslev work experience
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Visual Inspection Sme
Visual Inspection Sme
Global SME for visual inspection at Fujifilm’s new drug product CDMO facilities. Key contributor to establishing drug product capabilities by leading and driving deliverables for automated and manual visual inspection within the facilities.Tasks and responsibilities:- Lead on various work packages including process equipment, operational readiness, maintenance, qualification, and tech transfers.- Providing SME support for visual inspection during dialogue with customers.
Inspection Specialist
Process owner and Subject Matter Expert (SME) for the visual inspection processes in Xellia’s Finished Dosage Form (FDF) production. Tasks and responsibilities:- Ensuring visual inspection according to compendial and regulatory requirements (USP 1790/788/790, 21 CFR 210/211, EU GMP)- Validation/qualification of operators and inspection machines- Implementation of new product variants in the visual inspection program- Specification/creation/maintenance of validation/challenge kits- Preparation and execution of Knapp studies- Configuration and tuning (vision engineering) of Seidenader Fully Automatic Inspection Systems- Preparation of Standard Operating Procedures (SOPs) and Work Instructions (WIs) - Preparation of risk assessments and change controls- Handling of deviations and CAPAS- Establishment and management of statistical quality control program (acceptance sampling, control charts, capability)- Management of GxP compliant computerized systems according to GAMP5- Management of vendor and internal engineering activities for the inspection machines- Technical support of production facilities and equipment- Presenting at authority inspections and customer audits- Training of operators and technicians- LEAN (5S, 3C, A3, KATA) and board meetings- Assisting Global Technical Services in cases of customer complaints- Project management
Safety Engineer
-Risk assessment and evaluation by application of CSM-RA (EU 352/2009)-HAZOP and HAZID-Hazard mitigation
Database/Statistical Programmer
- Preparation of clinical datasets from the national health databases and the civil registration system (CPR-registeret) using SAS.- Archivation of databases according to the SIARD standard.- Advisement of researchers.
Student Assistant
Assisted in research by:- EMG measurements on baggage handlers in Copenhagen Airports.- Signal processing of EMG (electromyography) and motion data using MATLAB.
Officer Cadet
Simon Falkerslev education
Master Of Science (Msc), Medicine And Technology
Bachelor Of Science (Bsc), Biomedical/Medical Engineering
Frequently asked questions about Simon Falkerslev
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What company does Simon Falkerslev work for?
Simon Falkerslev works for FUJIFILM Diosynth Biotechnologies.
What is Simon Falkerslev's role at FUJIFILM Diosynth Biotechnologies?
Simon Falkerslev is listed as Visual inspection SME at FUJIFILM Diosynth Biotechnologies.
What is Simon Falkerslev's email address?
AeroLeads has found 1 work email signal at @student.dtu.dk for Simon Falkerslev at FUJIFILM Diosynth Biotechnologies.
Where is Simon Falkerslev based?
Simon Falkerslev is based in Copenhagen, Capital Region of Denmark, Denmark while working with FUJIFILM Diosynth Biotechnologies.
What companies has Simon Falkerslev worked for?
Simon Falkerslev has worked for Fujifilm Diosynth Biotechnologies, Xellia Pharmaceuticals, Banedanmark, Statens Serum Institut (National Institute For Health Data And Disease Control), and Department Of Neuroscience And Pharmacology, Division Of Biomechanics, University Of Copenhagen.
How can I contact Simon Falkerslev?
You can use AeroLeads to view verified contact signals for Simon Falkerslev at FUJIFILM Diosynth Biotechnologies, including work email, phone, and LinkedIn data when available.
What schools did Simon Falkerslev attend?
Simon Falkerslev holds Master Of Science (Msc), Medicine And Technology from Technical University Of Denmark.
What skills is Simon Falkerslev known for?
Simon Falkerslev is listed with skills including Digital Image Processing, Visual Inspection, Data Mining, Machine Learning, Gmp, Statistics, Biomedical Engineering, and Medical Imaging.
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