Amara El Madak - Qualification Engineer

Q: Where is Amara based?

Amara is based in Flörsheim am Main, Germany .

Q: What languages does Amara speak?

Amara speaks the following languages: Arabic (Native), German (Advanced), English (Advanced), French (Advanced) .

Q: How many years of experience does Amara have?

Amara has at least 25 years of experience. During this time, Amara has worked in at least 7 different roles and for 15 different companies . The average length of individual experience is 1 year and 5 months . Note that Amara may not have shared all experience and actually has more experience.

Q: What is Amara's latest experience?

Amara's most recent position is Qualification Engineer at Optima Pharma GmbH .

Q: What companies has Amara worked for in recent years?

In recent years, Amara has worked for Optima Pharma GmbH , Takeda Austria , BAG-Helthcare , Bbraun Sempach Schweiz , and CSL Behring GmbH .

Q: Which industries is Amara most experienced in?

Amara is most experienced in industries like Pharmaceutical , Healthcare , and Manufacturing . Amara also has some experience in Chemical and Biotechnology .

Q: Which business areas is Amara most experienced in?

Amara is most experienced in business areas like Quality Assurance , Product Development , and Project Management . Amara also has some experience in Marketing and Production .

Q: Which industries has Amara worked in recently?

Amara has recently worked in industries like Pharmaceutical , Healthcare , and Biotechnology .

Q: Which business areas has Amara worked in recently?

Amara has recently worked in business areas like Quality Assurance , Product Development , and Project Management .

Recommended expert

Flörsheim am Main, Germany

Check rate

Experience

Mar 2024 - Present

2 years 2 months

Schwäbisch Hall, Germany

Qualification Engineer

Optima Pharma GmbH

Qualification of filling lines
Preparation of IQ, OQ, PQ documents and reports
Execution of FAT and SAT
Alarm lists: create and perform tests
Preparation of GMP-compliant documentation (qualification plan, URS, risk analysis, IQ, OQ, PQ and qualification report)

Jul 2023 - Feb 2024

8 months

Austria

Qualification Engineer

Takeda Austria

Qualification of laboratory 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 months

Lich, Germany

Qualification Engineer

BAG-Helthcare

Qualification, requalification and periodic review of various systems: pure steam generator, compressed air generation, sterilizer ICOS, incubators, refrigerators, autoclave Sauter (temperature mapping), freeze-dryer, filling machine, hot air tunnel ST4, cleanroom ventilation system, sampling cabinet, monitoring of pharmaceutical production, WFI and HPW system, isolator
Sterilization of products in cleanroom class A and B

Jan 2022 - Sep 2022

9 months

Sempach, Switzerland

CSV Engineer

Bbraun Sempach Schweiz

Independent planning and execution of risk-based validation of computerized systems in the OT/IT field for drug and medical device production
Ensuring complete GxP-compliant documentation for the entire lifecycle of computerized systems according to GAMP 5 (changes, GAMP categorization, data integrity, risk analyses, traceability, specifications, test planning, test execution, reviews and deviations)
Specification of test cases, test prerequisites, test data, test scripts, test acceptance criteria as well as execution and documentation of these test cases
Consulting and support for process owners in connection with projects, commissioning and maintenance of GxP-relevant computerized systems
Participation in the continuous improvement of digitization and data integrity
Creation of FAT and SAT for a PLS system
Support as a validation expert in defining the validation strategy, executing validation, managing deviations, implementing CAPA measures and changes, and identifying possible solutions
Conducting training in the validation of computerized systems
Close coordination and collaboration with stakeholders on site and globally
Compilation and GMP evaluation of production data in the aseptic filling area, creation and follow-up of change control requests

Sep 2021 - Dec 2021

4 months

Bern, Switzerland

Qualification Engineer

CSL Behring GmbH

Cleanroom qualifications
Review of calibration certificates performed by external service providers
Review of qualification status of equipment
Checking ventilation logs
Assistance with revalidations of production equipment such as autoclaves, sterilization tunnels
Revision of documents and procedures
Review of qualification documentation for equipment (e.g. refrigerators, benchtop instruments, centrifuges, HPLC (method transfer))

May 2021 - Aug 2021

4 months

Project Engineer

Lonza GmbH

Organization, coordination, execution and enforcement of qualifications
Validations and routine introductions of complex systems under GMP in microbiology quality control and possibly involved sites
Clarifications and collaboration with QC Microbiology internally, with QA of various departments, with production sites and external companies
Consulting and theoretical and practical support for several system qualifications in USP/EP matters
Consulting and theoretical and practical support for multiple qualifications and validations of complex computer-controlled robotic systems under GMP in QC Microbiology
Change control and CAPA processing (Trackwise)

Nov 2020 - Apr 2021

6 months

Schwalbach am Taunus, Germany

Project Engineer

Siemens Healthcare Diagnostics Products GmbH

Checking the operability of software modules of the BNII V2.7 software on Mac OS 10.15.6 to ensure the basic functionality of the software for design verification
Planning and executing the developed tests
Evaluating and documenting the test results in the Imbus TestBench tool
Performing design verification of the BNII V2.7 software using test specifications and executing them on the BNII diagnostic system
Creating test specifications and applying existing ones in the Imbus TestBench test management tool and the SBM defect tracking tool

Mar 2020 - Oct 2020

8 months

Marburg, Germany

Qualification Engineer

CSL Behring GmbH

Qualification of equipment as part of SAT/FAT
Method validation (HPLC)
Qualification of a monitoring system: creating GMP-compliant documentation
Qualification of a packaging line in the sterile area
Method validation

Sep 2019 - Feb 2020

6 months

Validation Engineer

Lohmann & Rauscher GmbH

Commissioning of image processing systems on converting lines
Process validation of a converting line
Qualification of measuring equipment & process validation
Validation of computer systems according to GAMP
Software validation in the GMP environment
Commissioning of a new process control system
Qualification of the associated process control systems

Aug 2018 - Aug 2019

1 year 1 month

Munich, Germany

Validation Engineer

Formycon AG

Qualification coordinator: training employees on key qualification documents
Reviewing qualification documents on behalf of the QA department
Qualification of analytical instruments (HPLCs, UPLC, mass spectrometers, Cary 8454 photometer, UV-VIS spectrometer, ELISA reader, NIR spectrometer, centrifuges) and evaluation
Data integrity, CSV and user management configurations
Creating a master plan and a gap analysis
Qualification of freezers and refrigerators with mapping
Document support for requalification of equipment, systems and computer systems
Analysis of changes to equipment and systems
Discussing and tracking deviations
Creating and updating technical documentation, procedures and protocols
Method validation of analytical equipment

Jan 2018 - Jul 2018

7 months

Vienna, Austria

Validation Engineer

Shire AG

Qualification of various analytical instruments
Documentation support for requalification of equipment, systems and computer programs
Analysis of changes to equipment (BioTek Cytation5, HPLCs, photometers, centrifuges, filtration system)
Discussion and tracking of deviations
Creation and update of technical documentation, instructions and protocols
Data Integrity Assessment
Method validation

Mar 2017 - Dec 2017

10 months

Hettlingen, Switzerland

Validation Engineer

Akorn AG

Qualification of a sterile filling line (qualification and GMP-compliant documentation of the system and existing and new equipment)
Data Integrity project
Qualification of various analytical instruments (NIR spectrometers, HPLC, UPLC, viscometer, titration devices, centrifuges, drying oven, vacuum drying oven, turbidity meter, density meter, freezer, UV-VIS photometer, analytical, top-loading and microbalances)
Cleaning validation: pipette washer, cleaning and disinfection machine (with TOC measurements) and CIP stations
Documentation of qualification steps DQ, IQ, OQ, PQ plans, reports as well as device SOP creation and change control

Aug 2011 - Feb 2017

5 years 7 months

Schwalbach am Taunus, Germany

Test Engineer

Siemens Healthcare Diagnostics Products GmbH

System testing of diagnostic devices in a lab environment
Use of given test procedures (assessment of successful test or deviations)
Documentation of test execution and deviation/error observation in a test database and log file backup
Modification of written test procedures based on specification changes
Creation of new test procedures according to software specification
Test execution for various blood test systems (BNProSpec, Royal, BCSXP…)
Testing fluid systems (pumps), hardware and software

Sep 2009 - Jul 2011

1 year 11 months

Melsungen, Germany

Validation Engineer

Bbraun Melsungen

Validation and qualification
Preparation and writing of qualification documents (user requirements, DQ, IQ, OQ, PQ and alarm acceptance tests)
Risk assessment for lab systems (HPLCs, GCs, AAS etc.); qualification and documentation for systems: vessels
Cleaning validation: CIP stations
Ultra filtration system, compressed air distribution system, pure steam distribution system, purified water for production, thermal decontamination, lab equipment, autoclaves, sterilizers, laminar flow

Apr 2008 - Sep 2009

1 year 6 months

Ingelheim am Rhein, Germany

Validation Engineer

Boehringer Ingelheim

Validation of a blister line (EAS 420, Klöckner-Pentapack)
Packaging of medicines in blister packs
Team coordinator across qualification stages and phases (DQ, IQ, OQ, PQ) for system and product validation
Qualification of laminar flow units and cooling equipment
Writing validation plans, URS (user requirement specs), FS (functional specs) and risk analysis for various lab devices (HPLCs, GCs etc.)
Writing, execution and evaluation of qualification protocols for various systems in pharmaceuticals
Writing and resolution of technical deviations
Writing and summarizing qualification reports and tests

Aug 2004 - Aug 2007

3 years 1 month

Essen, Germany

Graduate Engineer in Chemical Engineering

BEC Bellenberg Engineering & Consulting

Designing a marketing strategy for complex technical products
Actively contributing to the creation of requirement and specification documents
Planning, conceptualizing, and constructing process engineering plants
Preparing technical proposals from the planning phase to customer acceptance in close coordination with sales

Jan 1997 - Jul 2000

3 years 7 months

Dortmund, Germany

Student Assistant

Elmos AG

Supporting an engineering team with project execution
Creating CAD drawings
Measuring particles in a cleanroom
Optimizing an exhaust air system

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical, Healthcare, Manufacturing, Chemical, and Biotechnology.

Pharmaceutical

Healthcare

Manufacturing

Chemical

Biotechnology

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Project Management, Product Development, Marketing, and Production.

Quality Assurance

Project Management

Product Development

Marketing

Production

Summary

challenging range of tasks

Skills

Ms Office 2000 (Very Good Knowledge)
Auto Cad (Very Good Knowledge)
Inventor6
Aspen Plus
Visio Technical
Html
Javascript
Filtration Technology
Materials Engineering
Mechanical Process Engineering
Plant Engineering
Mixing Technology
Thermal Process Engineering
Industrial Chemistry
Analytical Chemistry
Inorganic Chemistry
Chemical Analysis And Measurement Methods
Chemical Process Engineering
Laboratory Work
Laboratory Technology
International Pharmaceutical Standards (E.g. Glp, Gmp)
Pharmaceutical Technology
Production Planning
Quality Inspection
Quality Assurance
Plant Design (Utilities, Process Engineering)
Photovoltaics
Environmental Analysis
Experiment Execution And Evaluation
Process Analytics
Project Management
Waste Management

Languages

Arabic

Native

German

Advanced

English

Advanced

French

Advanced

Education

Mar 1994 - Aug 2001

University of Dortmund

Diploma in Engineering · Chemical Engineering · Dortmund, Germany

Sep 1988 - Jun 1992

Bouchuaib Doukkali University, Morocco

Diploma in Chemistry · Chemistry · El Jadida, Morocco

Certifications & licenses

Certificate in Automation Technology

URS Washington Division

Validation Officer

Concept Heidelberg

Energy Consultant for Renewable Energies

WBS Training Dortmund

Industrial Specialist in CAD Technology

RAG Bildung | Dortmund, North Rhine-Westphalia

Trainee Program teco

Institut für Berufliche Bildung GmbH (IBB) | Bottrop, North Rhine-Westphalia

Statistics

Experience

Total positions 17

Experience in Pharmaceutical 9.5 y

Avg length 1 y 5 m

Longest experience 5 y 6 m

Global Experience

Countries worked in 3 (Germany, Switzerland, Austria)

Primary country Germany

Expertise

Recent roles Qualification Engineer, CSV Engineer, Project Engineer

Main industries Pharmaceutical, Healthcare, Manufacturing

Main business areas Quality Assurance, Project Management, Product Development

Qualifications

Highest degree Bachelor

Certifications earned 5

Profile

Created

October 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Amara based?

Amara is based in Flörsheim am Main, Germany.

What languages does Amara speak?

Amara speaks the following languages: Arabic (Native), German (Advanced), English (Advanced), French (Advanced).

How many years of experience does Amara have?

Amara has at least 25 years of experience. During this time, Amara has worked in at least 7 different roles and for 15 different companies. The average length of individual experience is 1 year and 5 months. Note that Amara may not have shared all experience and actually has more experience.

What roles would Amara be best suited for?

Based on recent experience, Amara would be well-suited for roles such as: Qualification Engineer, CSV Engineer, Project Engineer.

What is Amara's latest experience?

Amara's most recent position is Qualification Engineer at Optima Pharma GmbH.

What companies has Amara worked for in recent years?

In recent years, Amara has worked for Optima Pharma GmbH, Takeda Austria, BAG-Helthcare, Bbraun Sempach Schweiz, and CSL Behring GmbH.

Which industries is Amara most experienced in?

Amara is most experienced in industries like Pharmaceutical, Healthcare, and Manufacturing. Amara also has some experience in Chemical and Biotechnology.

Which business areas is Amara most experienced in?

Amara is most experienced in business areas like Quality Assurance, Product Development, and Project Management. Amara also has some experience in Marketing and Production.

Which industries has Amara worked in recently?

Amara has recently worked in industries like Pharmaceutical, Healthcare, and Biotechnology.

Which business areas has Amara worked in recently?

Amara has recently worked in business areas like Quality Assurance, Product Development, and Project Management.

What is Amara's education?

Amara holds a Bachelor in Chemical Engineering from University of Dortmund.

Does Amara have any certificates?

Amara has 5 certificates. Among them, these include: Certificate in Automation Technology, Validation Officer, and Energy Consultant for Renewable Energies.

What is the availability of Amara?

Amara is immediately available for suitable projects.

What is the rate of Amara?

Amara's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.