Amara E.
Qualification Engineer
Experience
Mar 2024 - Present
1 year 8 monthsSchwäbisch Hall, Germany
Qualification Engineer
Optima Pharma GmbH
- Qualification of filling lines
- Preparation of IQ, OQ, PQ documents and reports
- Executing FAT and SAT
- Creating and performing alarm tests based on alarm lists
- Preparation of GMP-compliant documentation (qualification plan, URS, risk analysis, IQ, OQ, PQ and qualification report)
Jul 2023 - Feb 2024
8 monthsAustria
Qualification Engineer
Takeda Austria
- Qualification of lab equipment (Raman spectrometer, Image Compare, ELISA reader)
- Preparation of GMP-compliant documentation (qualification plan, URS, risk analysis, IQ, OQ, PQ and qualification report)
Oct 2022 - Jun 2023
9 monthsLich, Germany
Qualification Engineer
BAG-Helthcare
- Qualification, requalification and periodic reviews of various systems (pure steam generator, compressed air generation, ICOS sterilizer, incubators, refrigerators, Sauter autoclave with temperature mapping, freeze dryer, filling machine, ST4 hot air tunnel, cleanroom ventilation system, sample transfer cabinet, monitoring of pharmaceutical production, WFI and HPW system, isolator)
- Sterilization of products in cleanroom classes A and B
Jan 2022 - Sep 2022
9 monthsCSV Engineer
B. Braun
- Independent planning and execution of risk-based validation of computerized systems in the OT/IT area for pharmaceutical and medical device production
- Ensuring complete GxP-compliant documentation according to GAMP 5 (changes, categorization, data integrity, risk analyses, traceability, specifications, test planning, test execution, reviews and deviations)
- Specification and documentation of test cases, test prerequisites, test data, test scripts and acceptance criteria
- Advising and supporting process owners in projects, commissioning and maintenance of GxP-relevant systems
- Contributing to continuous improvement of digitization and data integrity
- Creating FAT and SAT documents for a PLS system
- Supporting as a validation expert in strategy, execution, deviation management, CAPA measures and problem solving
- Conducting trainings on validation of computerized systems
- Close coordination with local and global stakeholders
- Compiling and GMP assessment of production data in the field of aseptic filling
- Creating and tracking change control requests
Sep 2021 - Dec 2021
4 monthsBern, Switzerland
Qualification Engineer
CSL Behring GmbH
- Performing cleanroom qualifications
- Reviewing calibration certificates from external service providers
- Checking qualification status of equipment and ventilation protocols
- Supporting revalidation of production equipment (autoclaves, sterilization tunnels)
- Revising documents and procedures
- Reviewing qualification documentation of equipment (refrigerators, benchtop instruments, centrifuges, HPLC)
May 2021 - Aug 2021
4 monthsProject Engineer
Lonza GmbH
- Organization, coordination, execution, and enforcement of qualifications
- Validations and routine introductions of complex systems under GMP in microbiological quality control
- Coordination with internal QC microbiology, QA departments, production operations, and external companies
- Consultation and theoretical as well as practical support for system qualifications according to USP/EP
- Validation of complex computer-based robotic systems under GMP in QC microbiology
- Handling of change control and CAPA in Trackwise
Nov 2020 - Apr 2021
6 monthsProject Engineer
Siemens Healthcare Diagnostics Products GmbH
- Verification of the operability of BNII V2.7 software modules on macOS 10.15.6 to ensure basic functionality
- Planning and execution of test specifications
- Evaluation and documentation of test results in Imbus TestBench
- Design verification of BNII V2.7 software through test executions on the BNII diagnostic system
- Creation and application of test specifications in Imbus TestBench and defect tracking with SBM
Mar 2020 - Oct 2020
8 monthsQualification Engineer
CSL Behring GmbH
- Qualification of equipment as part of SAT and FAT
- Method validation using HPLC
- Qualification of a monitoring system with GMP-compliant documentation
- Qualification of a packaging line in the sterile area
- Method validation
Sep 2019 - Feb 2020
6 monthsValidation Engineer
Lohmann & Rauscher GmbH
- Commissioning of image processing systems on converting lines
- Process validation of a converting system
- Qualification of test equipment and process validation
- Validation of computer systems according to GAMP
- Software validation in the GMP environment
- Commissioning of a new process control system and its qualification
Aug 2018 - Aug 2019
1 year 1 monthMunich, Germany
Validation Engineer
Formycon AG
- Coordination and training of staff on qualification documents
- Review of qualification documents on behalf of the QA department
- Qualification of analytical equipment (HPLC, UPLC, MS, photometers, UV-VIS spectrometers, ELISA readers, NIR spectrometers, centrifuges)
- Data integrity, CSV, and user management configurations
- Creation of a master plan and GAP analysis
- Qualification of freezers and refrigerators including mapping
- Oversight of requalification of equipment, facilities, and systems
- Analysis of changes and tracking of deviations
- Creation and updating of technical documentation, instructions, and protocols
- Method validation of analytical equipment
Jan 2018 - Jul 2018
7 monthsVienna, Austria
Validation Engineer
Shire AG
- Qualification of various analytical instruments
- Managing the requalification of equipment, plants and computer systems
- Analysis of equipment modifications (BioTek Cytation5, HPLC, photometer, centrifuges, filtration system)
- Tracking deviations
- Creating and updating technical documentation, work instructions and protocols
- Data integrity assessment and method validation
Mar 2017 - Dec 2017
10 monthsHettlingen, Switzerland
Validation Engineer
Akorn AG
- Qualification of a sterile filling line with GMP-compliant documentation
- Carrying out a data integrity project
- Qualification of various analytical instruments (NIR, HPLC, UPLC, viscometer, titration units, centrifuges, drying ovens, microbalances)
- Cleaning validation of pipette washers, cleaning and disinfection machines, and CIP stations (with TOC measurements)
- Documenting all qualification steps (DQ, IQ, OQ, PQ), creating SOPs and change control
Aug 2011 - Feb 2017
5 years 7 monthsSchwalbach am Taunus, Germany
Test Engineer
Siemens Healthcare Diagnostics Products GmbH
- System testing of diagnostic instruments in a lab environment
- Executing predefined test procedures and evaluating results
- Documenting test execution, error observations and saving log files
- Modifying and creating test procedures according to specifications
- Testing blood test systems (BNProSpec, Royal, BCSXP) and fluid systems, hardware and software
Sep 2009 - Jul 2011
1 year 11 monthsValidation Engineer
B. Braun Melsungen
- Validation and qualification of lab and production systems
- Preparing qualification documents (requirements specification, DQ, IQ, OQ, PQ, alarm acceptance tests)
- Risk assessment for lab systems (HPLC, GC, AAS)
- Cleaning validation of CIP stations
- Validation of ultrafiltration, compressed air distribution systems, pure steam distribution, water treatment, autoclaves and sterilizers
Apr 2008 - Sep 2009
1 year 6 monthsValidation Engineer
Boehringer Ingelheim
- Validation of a blister line (EAS 420, Klöckner-Pentapack)
- Qualification of laminar flow units and cooling devices
- Coordinating qualification phases (DQ, IQ, OQ, PQ) for system and product validation
- Creating validation plans, URS, functional specifications and risk analyses for lab equipment
- Executing and evaluating qualification protocols and deviation management
Aug 2004 - Aug 2007
3 years 1 monthEssen, Germany
Graduate Engineer in Chemical Engineering
BEC Bellenberg Engineering & Consulting
- Designing a marketing strategy for complex technical products
- Helping create requirements and specification documents
- Planning, designing and building process engineering systems
- Preparing technical proposals until customer acceptance
Jan 1997 - Jul 2000
3 years 7 monthsDortmund, Germany
Student Assistant
Elmos AG
- Supporting an engineering team with project execution
- Creating CAD drawings
- Measuring particles in the cleanroom
- Optimizing an exhaust air system
Summary
challenging responsibilities
Languages
Arabic
NativeGerman
AdvancedEnglish
AdvancedFrench
AdvancedEducation
Mar 1994 - Aug 2001
University of Dortmund
Diploma in Engineering · Chemical Engineering · Dortmund, Germany
Sep 1988 - Jun 1992
Chouaib Doukkali University
Diploma in Chemistry · Chemistry · El Jadida, Morocco
Certifications & licenses
Certificate in Automation Technology
URS Washington Division
Validation Officer
Concept Heidelberg
Energy Consultant in Renewable Energies
WBS Training Dortmund
Certificate (Industrial Specialist for CAD Technology)
RAG Bildung
Certificate (Trainee Program teco)
Institut für Berufliche Bildung GmbH (IBB)
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