Engineering und Qualifikation im pharmazeutischen und chemischen Umfeld
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- 68535 Edingen-Neckarhausen
- Europa
- de | en
- 12.05.2020
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
1/2018 – offen
Tätigkeitsbeschreibung
- Planung Innenausbau (Reinräume) für ein Industriegebäude über 3 Stockwerke
- Planung HVAC, Medien
- Planung primärer Schutzmaßnahmen (Containment)
- Planung Rohbau Industriegebäude über 6 Stockwerke und Innenausbau mit Reinräumen, HVAC und Medien
- Projektplanung
- Einholen von Angeboten, Leistungsvergleich verschiedener Lieferanten
- Kostenkontrolle
Technische Konzeption
11/2017 – offen
Tätigkeitsbeschreibung
Consultant for the project: Aseptic vial filling of high potent substances
Skan AG, Allschwil, Switzerland
• GMP risk assessment
• Safety risk assessment for the operators (high potent substances)
• Isolator for sterile filling and placing the stoppers
• Batching tank inside the sterile isolator
• Detecting the GMP risks at the system for preparing a Riboflavin test to detect the critical spots
Maschinenbau, Good Manufacturing Practices
5/2016 – 6/2018
Tätigkeitsbeschreibung
Consultant for the project: High containment tablet press and
reconstruction of a suitable production area. Engineering of the
reconstruction measurements for implementation of the tablet press.
General consulting for technical tasks in the department.
Project lead for implementation of the tablet press, including all technical processes for with feeding with granule, sampling, bad tablet transfer, tablet dedusting, metal check and collecting the tablets.
Project lead for all necessary reconstructions for operation of the tablet press:
New purified water plant with loop, HVAC, waste water system and cleanrooms.
Actelion / Idorsia Pharmaceuticals Ltd, Switzerland
• Selection of a suitable containment tablet press and supplier
• Project lead for the complete implementation
• Determination of cost and cost control
• Risk assessment for product safety
• Risk assessment for employee safety
• General consulting of technical tasks in the department
• General consulting of GMP tasks in the department
Projektdurchführung
4/2016 – 9/2017
Tätigkeitsbeschreibung
Consultant for the project: Establishing of containment solutions
for a GMP production (weighing to coating) and packing plant.
Intervet GmbH, Vienna
• Development of the containment measurements under GMP aspects
• Manufacturing building, material and personal locks, tablet press,
weighing, granulation, coating and R&D equipment
• Risk assessment for product safety
• Risk assessment for employee safety
• Costing, supplier selection
Technische Konzeption
5/2015 – 4/2016
Tätigkeitsbeschreibung
Consultant for the project: Development of a prototype machine
for a new method of drug production
Maag Automatik GmbH, Großostheim
• Development of the machine
• GMP consulting for the machine manufacturer
• GMP Consulting for the pharmaceutical manufacturer
• Risk assessment
• Costing, supplier selection
• Definition of the specifications
• Creating specifications
Forschung & Entwicklung
12/2014 – 2/2015
Tätigkeitsbeschreibung
• Qualification of new equipment
• Requalification
• CAPA
• Change control
• Risk assessment
• Creation of IQ, OQ plans
• Commissioning, FAT/SAT
Good Manufacturing Practices
7/2014 – 2/2016
Tätigkeitsbeschreibung
Consultant for the project: Isolators for the manufacture of development batches with highly active substances in the field of weighing, mixing, tableting, drying and coating.
Hexal AG, Holzkirchen
• Advice on containment strategies for all production, cleaning and waste disposal operations
• Planning the appropriate systems
• Risk assessment
• Creation of SOPs and BAs
Technische Beratung
5/2013 – 7/2014
Tätigkeitsbeschreibung
Project manager / part-project manager for the project Vacuum Roller Dryer. Technology development for the drying of highly active ingredients. Including agitator vessel for the manufacture of API and org. Solvents.
AbbVie GmbH co. KG
• Development of manufacturing process and the production flow under GMP aspects
• Determination of the specifications
• Identification and selection of suppliers
• Cost plan
• Setting of parameters and preparation of the measuring points lists
Technische Konzeption
1/2009 – 11/2011
Tätigkeitsbeschreibung
Project management and part project manager for the project weight isolator. Installing of a stainless steel isolator (SKAN) for the usage in GMP field
Abbott GmbH & co. KG
• Definition of specifications
• Creating specifications
• Selection of suppliers, design configuration
• Cost plan
• Implementing Mock-Up
• Risk assessment
• Drawing up emergency procedure at product outlet
• Creating SOPs
• Installation of the system
• Carrying out FAT, SAT
• Commissioning
• Implementation training
Technische Konzeption
1/2008 – 8/2008
Tätigkeitsbeschreibung
Project manager for the reconstruction of a GMP pilot plant for the processing of highly active substances
Abbott GmbH & co. KG
• Installation of soft wall isolators
• Development of containment systems for the weighing, sieving, mixing, extrusion, tableting and coating
• Supplier selection, design configuration, costing and price negotiations
• Time planning
• Risk assessments
• Creating emergency procedure for accident product outlet
• Creating SOPs
• Creation of IQ, OQ plans
• Installation of the systems
• Carrying out FAT, SAT
• Qualification / commissioning
• Implementation training
Technische Konzeption
2/2006 – 11/2006
Tätigkeitsbeschreibung
Project management / project manager (staff side). Automation for fluid bed dryers and coater (Felten) AstraZeneca GmbH
• Risk assessment
• Development of the user interface
• Development of control software
• Installation
• Creating SOPs
• Creation of IQ, OQ plans
• Qualification / commissioning
• Implementation training
Technische Konzeption
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Weitere Kenntnisse
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Gut)
- Europäische Union
- Schweiz
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