IT, CSV, SAP PM/MM and COMOS Expert
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- 79539 Lörrach
- Europa
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- 08.03.2021
Kurzvorstellung
5 Years Experience in CSV for Pharma industry based on ISPE GAMP 5, FDA 21 CFR Part 11
13 years experience with Comos and SAP PM/MM
Qualifikationen
Projekt‐ & Berufserfahrung
9/2019 – 1/2020
Tätigkeitsbeschreibung
Design engineering master documents for P&ID including symbols of process and piping equipments
Design master data for process equipment define catalogs of pipe classes.
General Comos Customizing including visual basic scripting
Computer Aided Engineering, Dokumentenmanagement, Engineering data management (EDM), Technische Dokumentation, Visual Basic
3/2018 – 3/2021
Tätigkeitsbeschreibung
▪ Implementation of legal and regulatory requirements in the Asset Management department to prevent of failure of safety equipments and ensure agreement to environmental protection and human safety standards
▪ Overall responsible for SAP system in all aspects of asset and plant management (SAP PM, MM and CO)
▪ Test and validate new SAP functionalities and new releases
▪ Assisting in setting a document management system
▪ Define reporting concept and document management for audits and proof of maintenance
▪ Ensure correct execution of Asset Maintenance and Reliability Management processes by site users
▪ Support sites users in the execution of their tasks in SAP
▪ Provide advice for customization and new functionalities in SAP PM/MM and CO
▪ Develop training concept and documentation for site users in the maintenance and operation department
▪ Monitor maintenance activities, ensure correct execution of maintenance orders and optimize Asset Management and Reliability KPIs
▪ Participate in Risk Assessment and FMEA of critical process equipments
▪ Convert of Risk Assessment, FMEA and RCPS results into maintenance plan in SAP PM
▪ Standardize and Implement maintenance plans and tasks in SAP (Time- and performance-based)
▪ Define of maintenance BOM of critical equipments and develop strategy for effective materials coordination
▪ Support warehouse and inventory management
▪ Analyze incidents history of safety equipments and develop maintenance strategy to reduce their failure and improve plant availability.
▪ Implement catalogs and classification of object parts, damage, and activities codes within SAP PM
▪ Provide process and functional advices in SAP to solve specific business problems within maintenance and manufacturing
▪ Training of maintenance and operation stakeholders and ensure successful deployment of new SAP release within the site
▪ Configuration of controlling functionalities in SAP CO for time, budget and cost management within CAPEX projects
Engineering data management (EDM), FMEA (Failure Mode and Effects Analysis), Installation / Montage / Wartung (allg.), Instandhaltungsplanung, Arbeitsfähigkeit, Sap Mm, Sap Pm
5/2016 – 8/2016
Tätigkeitsbeschreibung
Comos Right Management
Comos Customizing
Software Architecture, Softwareanforderungsanalyse, C#, Vbscript, Technisches Projektmanagement
12/2012 – 2/2018
Tätigkeitsbeschreibung
▪ GMP compliant data management and engineering support in a greenfield biopharma plant engineering project built in Singapore, over complete lifecycle, from conceptual design, commission and construction till operation and maintenance
▪ Validation of process equipments and ensure correct data handover during transition from design and commissioning to operation and maintenance
▪ Writing and maintaining GMP validation documents (user requirement and functional specifications, tests and user manuals (SOP, URS, FS, OQ, PQ, FRA and IQ) following GAMP5 principles. Document involved in the plant management.
▪ Change management and test supervision
Develop training documents and provide GMP compliant training to stakeholders including key users and site employees
▪ Develop interfaces between CAD/CAE system and SAP PM & MM using ABAP via SAP PI to automatically synchronize plant data and creation of technical objects in SAP
▪ Configure and implement SAP PM & MM during transition from engineering to operation
▪ Define and implement processes and functionalities for effective spare parts and inventory management in SAP MM
▪ Administration of SAP PM MM and CAE-systems COMOS over the complete life cycle of the plant
▪ COMOS Customizing and programming while respecting GMP Standards
▪ Develop solutions to harmonize data within SAP PM, MM and CAE systems
▪ COMOS business support and Trouble Shooting
▪ Training of design engineers in P&ID and E&IC drawing with COMOS
▪ Develop small programs in Visual Basic and C# including SQL
Anlagentechnik, C#, Code-Review, Elektrotechnik, Engineering data management (EDM), Instandhaltungsplanung, Microsoft SQL-Server (MS SQL), Projektmanagement (IT), Workflows, Sap Mm, Sap Pm, Software Architecture, Technische Beratung, Computer Engineering, Test Management, Verfahrenstechnik (allg.), Vbscript
11/2011 – 12/2012
Tätigkeitsbeschreibung
Optimierung von Engineering Prozess,
Effektiver Einsatz von Engineering Systemen
Comos Performanzanalyse
Krisenprojekt Consulting
Systemengineering
Systemmodellierung
Computer Engineering, Embedded Systems, Software Design, Softwareanforderungsanalyse, Engineering data management (EDM)
6/2007 – 10/2011
Tätigkeitsbeschreibung
Product Lifecyclemanagement,
Comos Customizing
Requirement Engineering
Technical Project Management,
Software development
Sales Support
Concept development in Project Engineering
Microsoft SQL-Server (MS SQL), Software Design, Objektorientierte Software-Entwicklung, Anlagentechnik, Engineering data management (EDM)
Ausbildung
Phoenix, USA
Duisburg Essen
Weitere Kenntnisse
Persönliche Daten
- Deutsch (Fließend)
- Englisch (Fließend)
- Französisch (Muttersprache)
- Europäische Union
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