Independent planning, execution and documentation of IQ and OQ activities for GMP-regulated pharmaceutical filling systems.
Execution of international FAT and SAT activities for pharmaceutical customers in Europe, USA and Middle East.
Preparation and maintenance of RTM (Requirement Traceability Matrix) and TPM (Test Plan Matrix).
Functional testing and verification of HMI, PLC and machine functions according to GMP requirements.
Troubleshooting and technical issue resolution in collaboration with automation, mechanical, electrical and project management teams.
Support of project coordination, risk communication and technical status reporting.
Execution of qualification activities according to GDP and pharmaceutical documentation standards.
Collaboration within interdisciplinary and international project environments.
Selected Projects: FAT/SAT execution for filling lines at Boehringer Ingelheim, AstraZeneca, Amgen and Thermo Fisher projects in USA and Italy.
Optima Pharma/ B4QS, Schwäbisch Hall
7 months
2023-06 - 2023-12
Preparation of the Bachelor's thesis
Development and validation of a testing rig for automotive body manufacturing applications.
Design optimization and validation using CAD and simulation tools.
Planning, procurement, assembly and implementation of the testing system.
Execution of durability and pulsator cycle testing.
Heilbronn University Research Center, Heilbronn
5 months
2023-02 - 2023-06
Supplier Quality Electronics / Electrical
Intern
Intern
Development of supplier quality management structures for internal usage restrictions (IVB).
Creation of VBA-based Excel automation tools.
Participation in cross-functional coordination meetings.
Support of infotainment hardware/software test bench activities.
Audi AG
Aus- und Weiterbildung
Aus- und Weiterbildung
2020 - 2024 Studie - Mechanical Engineering Heilbronn University Degree: Bachelor of Engineering
Position
Position
Qualification Engineer
Kompetenzen
Kompetenzen
Top-Skills
MS OfficeSAPMATLABCATIA V5Good Manufacturing PracticeQualifizierungsdokumentQualifizierungsingenieurValidierungKollaboratives ProjektmanagementProblemanalyseIssue Tracking System
Produkte / Standards / Erfahrungen / Methoden
Skills
GMP/ EU-GMP/ Annex 15
IQ/ OQ Qualification
FAT/ SAT Execution
CQV Support
Requirement Traceability
Matrix (RTM)
Test Plan Matrix (TPM)
Risk-Based Qualification
GDP Documentation
Pharmaceutical Filling
Systems
HMI/ PLC Functional Testing
Technical Troubleshooting
International Project
Execution
Project Coordination
IT skills
Python
MATLAB
CATIA V5
MS Office
Additional Information
Available for freelance CQV / Qualification projects
Experience in international pharmaceutical project environments
Einsatzorte
Einsatzorte
Deutschland, Schweiz, Österreich
möglich
Projekte
Projekte
2 years 6 months
2023-12 - 2026-05
various
Qualification Engineer (External)
Qualification Engineer (External)
Independent planning, execution and documentation of IQ and OQ activities for GMP-regulated pharmaceutical filling systems.
Execution of international FAT and SAT activities for pharmaceutical customers in Europe, USA and Middle East.
Preparation and maintenance of RTM (Requirement Traceability Matrix) and TPM (Test Plan Matrix).
Functional testing and verification of HMI, PLC and machine functions according to GMP requirements.
Troubleshooting and technical issue resolution in collaboration with automation, mechanical, electrical and project management teams.
Support of project coordination, risk communication and technical status reporting.
Execution of qualification activities according to GDP and pharmaceutical documentation standards.
Collaboration within interdisciplinary and international project environments.
Selected Projects: FAT/SAT execution for filling lines at Boehringer Ingelheim, AstraZeneca, Amgen and Thermo Fisher projects in USA and Italy.
Optima Pharma/ B4QS, Schwäbisch Hall
7 months
2023-06 - 2023-12
Preparation of the Bachelor's thesis
Development and validation of a testing rig for automotive body manufacturing applications.
Design optimization and validation using CAD and simulation tools.
Planning, procurement, assembly and implementation of the testing system.
Execution of durability and pulsator cycle testing.
Heilbronn University Research Center, Heilbronn
5 months
2023-02 - 2023-06
Supplier Quality Electronics / Electrical
Intern
Intern
Development of supplier quality management structures for internal usage restrictions (IVB).
Creation of VBA-based Excel automation tools.
Participation in cross-functional coordination meetings.
Support of infotainment hardware/software test bench activities.
Audi AG
Aus- und Weiterbildung
Aus- und Weiterbildung
2020 - 2024 Studie - Mechanical Engineering Heilbronn University Degree: Bachelor of Engineering
Position
Position
Qualification Engineer
Kompetenzen
Kompetenzen
Top-Skills
MS OfficeSAPMATLABCATIA V5Good Manufacturing PracticeQualifizierungsdokumentQualifizierungsingenieurValidierungKollaboratives ProjektmanagementProblemanalyseIssue Tracking System
Produkte / Standards / Erfahrungen / Methoden
Skills
GMP/ EU-GMP/ Annex 15
IQ/ OQ Qualification
FAT/ SAT Execution
CQV Support
Requirement Traceability
Matrix (RTM)
Test Plan Matrix (TPM)
Risk-Based Qualification
GDP Documentation
Pharmaceutical Filling
Systems
HMI/ PLC Functional Testing
Technical Troubleshooting
International Project
Execution
Project Coordination
IT skills
Python
MATLAB
CATIA V5
MS Office
Additional Information
Available for freelance CQV / Qualification projects
Experience in international pharmaceutical project environments
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