Amara El Madak - Qualification Engineer for GMP Pharma

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Flörsheim am Main, Germany

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Experience

Mar 2024 - Present

2 years 9 months

Schwäbisch Hall, Germany

Qualification Engineer

Optima Pharma GmbH

Qualification of filling lines
Preparation of IQ, OQ, PQ documents and reports
Conducting FAT and SAT
Alarm lists: creating and performing 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 generators, compressed air generation, ICOS sterilizer, incubators, refrigerators, Sauter autoclave (temperature mapping), freeze dryer, filling machine, ST4 hot air tunnel, cleanroom ventilation system, sampling booth, pharmaceutical production monitoring, WFI and HPW systems, isolator
Sterilization of products in Class A and B cleanrooms

Jan 2022 - Sep 2022

9 months

Sempach, Switzerland

CSV Engineer

Bbraun Sempach Schweiz

Independently planning and performing risk-based validation of computerized systems in the OT/IT area for the production of medicinal products and medical devices
Ensuring complete, GxP-compliant documentation throughout the entire lifecycle of computerized systems in accordance with GAMP 5 (changes, GAMP categorization, data integrity, risk analyses, traceability, specifications, test planning, test execution, reviews and deviations)
Specifying test cases, test prerequisites, test data, test scripts and test acceptance criteria, and executing and documenting these test cases
Advising and supporting process owners in connection with projects, commissioning and maintenance of GxP-relevant computerized systems
Contributing to the continuous improvement of digitalization and data integrity
Preparing FAT and SAT for a PLS system
Supporting as a validation expert in defining the validation strategy, performing validation, handling deviations, implementing CAPA measures and changes, and identifying possible solutions
Delivering training in the area of computerized systems validation
Close coordination and collaboration with stakeholders at the site and globally
Compiling and GMP-assessing production data in the area of aseptic filling, preparing and following up on CC requests

Sep 2021 - Dec 2021

4 months

Bern, Switzerland

Qualification Engineer

CSL Behring GmbH

Cleanroom qualifications
Reviewing calibration certificates issued by external service providers
Checking the qualification status of equipment
Reviewing ventilation logs
Assisting with revalidations of production equipment, such as autoclaves and sterilization tunnels
Revising documents and procedures
Reviewing equipment qualification documentation (such as refrigerators, bench-top measuring devices, centrifuges, HPLC (method transfer))

May 2021 - Aug 2021

4 months

Project Engineer

Lonza GmbH

Organization, coordination, execution and enforcement of qualifications
Validations and routine implementation of complex systems under GMP in Quality Control Microbiology and, where applicable, the involved operating units
Clarifications and collaboration with QC Microbiology internally, with QA in various departments, with production units and external companies
Consulting and theoretical and practical support for several system qualifications concerning USP/EP matters
Consulting and theoretical and practical support for several 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 the Mac 10.156 operating system to ensure the software's basic functionality for design verification
Planning and carrying out the tests that were developed
Evaluating and documenting test results in the Imbus TestBench Tool
Design verification of the BNII V2.7 software using test specifications and their execution on the BNII diagnostic system
Developing test specifications and applying existing test specifications 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: preparation of GMP-compliant documentation
Qualification of a packaging line in a sterile area
Method validation

Sep 2019 - Feb 2020

6 months

Validation Engineer

Lohmann & Rauscher GmbH

Commissioning of image processing systems on converting equipment
Process validation of a converting line
Test equipment qualification & process validation
Validation of computer systems according to GAMP
Software validation in the GMP area
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 Quality Management department
Qualification and evaluation of analytical equipment (HPLCs, UPLC, mass spectrometers, Cary 8454 photometer, UV-VIS spectrometer, Elisa Reader, NIR spectrometer, centrifuges)
Data Integrity, CSV and user management configurations
Preparation of a master plan and a GAP analysis
Qualification of freezers and refrigerators, including mapping
Documentation support for the requalification of equipment, systems and computer systems
Analysis of changes to equipment and systems
Discussion and follow-up of deviations
Preparation and updating of technical documentation, instructions 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 the requalification of instruments, equipment and computer systems
Analysis of changes to instruments (BioTek Cytation5, HPLCs, photometers, centrifuges, filtration system)
Discussion and follow-up of deviations
Preparation 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 filling line in the sterile area (qualification and GMP-compliant documentation of the equipment and existing and newly acquired instruments)
Data Integrity project
Qualification of various analytical instruments (NIR spectrometer, HPLC, UPLC, viscometer, titration instruments, centrifuges, drying oven, vacuum drying oven, turbidity meter, density meter, freezer, UV-VIS photometer, analytical, top-loading and microbalances)
Cleaning validation: pipette washer, washer-disinfector (with TOC measurements) and CIP stations
Documentation of qualification steps: DQ, IQ, OQ, PQ plans and reports, as well as preparation of instrument SOPs 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 instruments in a laboratory environment
Use of prescribed test procedures (assessment of whether the test was successful or deviations occurred)
Documentation of test execution and deviation/error observations in a test database, as well as log file archiving
Modification of written test procedures based on specification changes
Creation of new test procedures according to the software specification
Testing of various blood testing systems (BNProSpec, Royal, BCSXP…)
Testing of 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 drafting of qualification documents (URS, DQ, IQ, OQ, PQ and Alarm Acceptance Tests)
Risk assessment for laboratory 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, laboratory equipment, autoclaves, sterilizers, laminar flow units

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 the various qualification levels and phases (DQ, IQ, OQ, PQ) for system and product validation
Qualification of laminar flow units and refrigeration equipment
Writing validation plans, URS (user requirement specifications), SS (design specifications) and risk analyses for various laboratory instruments (HPLCs, GCs etc.)
Writing, executing and evaluating qualification protocols for various systems in the pharmaceutical industry
Writing and resolving technical deviations
Writing and summarizing qualification reports and tests

Aug 2004 - Aug 2007

3 years 1 month

Essen, Germany

Employee as Dipl.-Ing in Chemical Engineering

BEC Bellenberg Engineering & Consulting

Developed a marketing strategy for complex technical products
Actively contributed to preparing specifications and requirements documents
Planned, designed, and built process engineering plants
Prepared technical proposals from the planning stage through customer acceptance, in close coordination with the sales team

Jan 1997 - Jul 2000

3 years 7 months

Dortmund, Germany

Student Assistant

Elmos AG

Supported an engineering group in managing projects
Created CAD drawings
Measured particles in a cleanroom
Optimized 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

Demanding area of responsibility

Skills

Ms Office 2000 (Very Good Knowledge)
Auto Cad (Very Good Knowledge)
Inventor6
Aspen Plus
Visio Technical
Html
Javascript
Filtration Technology
Materials Technology
Mechanical Process Engineering
Plant Technology
Mixing Technology
Thermal Process Engineering
Technical Chemistry
Analytical Chemistry
Inorganic Chemistry
Chemical Testing 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 Engineering (Utilities, Process Engineering)
Photovoltaics
Environmental Analysis
Conducting And Evaluating Experiments
Process Analytics
Project Management
Waste Treatment

Languages

Arabic

Native

German

Advanced

English

Advanced

French

Advanced

Education

Mar 1994 - Aug 2001

Universität Dortmund

Diplom-Ingenieur · Chemical Engineering · Dortmund, Germany

Sep 1988 - Jun 1992

Universität Bouchuaib Doukkali Marokko

Diplom Chemie · Chemistry · El Jadida, Morocco

Certifications & licenses

Automation Technology Certificate

URS Washington Division

Validation Officer

Concept Heidelberg

Energy Consultant for Renewable Energies

WBS Training Dortmund

Industrial Specialist for CAD Technology

RAG Bildung | Dortmund, Nordrhein-Westfalen

Trainee Program teco

Institut für Berufliche Bildung GmbH (IBB) | Bottrop, Nordrhein-Westfalen

Statistics

Experience

Total positions 17

Experience in Pharmaceutical 10 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

Member since

October 2025

Last update

October 2026

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Frequently asked questions

Have questions? Find more information here.

Amara is based in Flörsheim am Main, Germany.

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

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 2 years and 6 months. Note that Amara may not have shared all experience and actually has more experience.

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

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

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

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

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

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

Amara has recently worked in business areas like Quality Assurance.

Amara holds a Bachelor in Chemical Engineering from Universität Dortmund.

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

The availability of Amara needs to be confirmed.

Daily rate distribution

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Daily rate avg. 895 €

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Median rate 840 €

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Calculated based on our freelancers’ daily rates as of 7 Nov 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.