Recommended expert

Hayat Bouknine

Qualification & Validation Engineer – Equipment and Utilities

Hayat Bouknine
Sankt Johann, Germany

Experience

Sep 2025 - Present
6 months
Paris, France

Qualification & Validation Engineer – Equipment and Utilities

SOPHARTEX

  • Executed IQ/OQ/PQ for equipment and technical utility systems (HVAC, purified water, compressed air, clean steam).
  • Managed and closed audit deviations and CAPA.
  • Performed and tracked risk analyses (FMEA, criticality).
  • Updated procedures and validation plans.
  • Coordinated across departments and participated in audits.
May 2024 - Oct 2024
6 months

Deputy Qualification Manager

CURIUM

  • Created, reviewed, and approved IQ/OQ/PQ protocols and reports.
  • Developed work instructions for new equipment.
  • Monitored the site-specific validation plan.
  • Validated computer systems (URS, RA, testing, deviations).
  • Trained and supported teams.
Jan 2024 - Apr 2024
4 months

Qualification/Validation Lead – Operational Quality Assurance

APTAR

  • Developed and implemented the site-specific validation plan.
  • Created IQ/OQ/PQ templates and updated procedures.
  • Qualified and requalified equipment.
  • Managed deviations and CAPA.
Feb 2023 - Dec 2023
11 months
Val-de-Reuil, France

Qualification/Validation Consultant

SANOFI

  • Led technical meetings and managed scheduling.
  • Developed URS and IQ/OQ/PQ protocols and reports.
  • Qualified cold rooms.
Mar 2022 - Feb 2023
1 year
Évreux, France

Qualification/Validation Consultant

GSK

  • Prepared and executed FAT/SAT/VPL/IQ/OQ/PQ.
  • Conducted risk analyses and managed CAPA and deviations.
  • Qualified production equipment (filling line, labeling machine, reactors).
Jan 2020 - Dec 2022
3 years
Val-de-Reuil, France

Environmental Qualification Technician

VALDEPHARM

  • Qualification of HVAC, compressed air, nitrogen systems, LAF and lab exhausts.
  • Environmental tests (particle classification, RH/T, HEPA tests).
  • Development of procedures and handling deviations.
Jan 2019 - Dec 2020
2 years
Notre-Dame-de-Bondeville, France

Filling Line Leader – Sterile Production

ASPEN

Jan 2018 - Dec 2019
2 years
Val-de-Reuil, France

Production Support Technician

SANOFI

Jan 2017 - Dec 2018
2 years
Le Trait, France

Visual Inspection Line Operator

SANOFI

Jan 2010 - Dec 2017
8 years

Pharmaceutical Technical Assistant

Apotheke

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (8 years), Healthcare (8 years), and Manufacturing (0.5 years).

Pharmaceutical
Healthcare
Manufacturing

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Customer Service (8 years), Quality Assurance (7 years), Production (5 years), and Operations (0.5 years).

Customer Service
Quality Assurance
Production
Operations

Summary

Qualification and validation expert with over 10 years of experience in the pharmaceutical industry. Solid knowledge in GMP environments, equipment and utility qualification, as well as computer systems (CSV). Structured, audit-experienced professional with strong interface management skills.

Skills

  • Qualification / Validation: Iq/oq/pq, Fat/sat, Risk Analysis, Csv.
  • Quality Management: Deviations, Capa, Audits, Sops, Gmp, Iso 9001:2015.
  • Project Management: Planning, Cross-department Coordination, Kpi Tracking, Reporting.
  • Tools: Geod, Gibraltar, Phenix, Qualipso, Iv Tracer, Preference, Domava.
  • Methods: Fmea, 5w2h, Pdca, 5s, Brainstorming.

Languages

French
Native
English
Advanced
German
Elementary

Education

Oct 2017 - Jun 2018

TSPCI · Pharmaceutical and Cosmetic Industry

Oct 2011 - Jun 2013

BP – PTA · PTA

Oct 2005 - Jun 2008

Bachelor in Biology · Biology

...and 1 more

Profile

Created
Need a freelancer? Find your match in seconds.
Try FRATCH GPT
More actions

Frequently asked questions

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

Where is Hayat based?

Hayat is based in Sankt Johann, Germany.

What languages does Hayat speak?

Hayat speaks the following languages: French (Native), English (Advanced), German (Elementary).

How many years of experience does Hayat have?

Hayat has at least 15 years of experience. During this time, Hayat has worked in at least 9 different roles and for 8 different companies. The average length of individual experience is 2 years and 6 months. Note that Hayat may not have shared all experience and actually has more experience.

What roles would Hayat be best suited for?

Based on recent experience, Hayat would be well-suited for roles such as: Qualification & Validation Engineer – Equipment and Utilities, Deputy Qualification Manager, Qualification/Validation Lead – Operational Quality Assurance.

What is Hayat's latest experience?

Hayat's most recent position is Qualification & Validation Engineer – Equipment and Utilities at SOPHARTEX.

What companies has Hayat worked for in recent years?

In recent years, Hayat has worked for SOPHARTEX, CURIUM, APTAR, SANOFI, and GSK.

Which industries is Hayat most experienced in?

Hayat is most experienced in industries like Pharmaceutical, Healthcare, and Manufacturing.

Which business areas is Hayat most experienced in?

Hayat is most experienced in business areas like Customer Service, Quality Assurance (QA), and Production/Manufacturing. Hayat also has some experience in Operations.

Which industries has Hayat worked in recently?

Hayat has recently worked in industries like Pharmaceutical and Manufacturing.

Which business areas has Hayat worked in recently?

Hayat has recently worked in business areas like Quality Assurance (QA), Production/Manufacturing, and Operations.

What is Hayat's education?

Hayat holds a Bachelor in Biology.

What is the availability of Hayat?

Hayat is immediately available full-time for suitable projects.

What is the rate of Hayat?

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

How to hire Hayat?

To hire Hayat, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

1200
900
600
300
Market avg: 890-1050 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.