Hayat Bouknine

Qualification & Validation Engineer – Equipment and Utilities

Hayat Bouknine
Sankt Johann, Germany

Experience

Sep 2025 - Present
5 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

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
Lorem ipsum dolor sit amet

TSPCI · Pharmaceutical and Cosmetic Industry

Oct 2011 - Jun 2013
Lorem ipsum dolor sit amet

BP – PTA · PTA

Oct 2005 - Jun 2008
Lorem ipsum dolor sit amet

Bachelor in Biology · Biology

...and 1 more
Need a freelancer? Find your match in seconds.
Try FRATCH GPT
More actions

Similar Freelancers

Discover other experts with similar qualifications and experience

Monika Weber
Monika Weber

Quality Specialist

View Profile
Benjamin Kraus
Benjamin Kraus

MDR Transition with PRRC-Function

View Profile
Jovan Jelic
Jovan Jelic

CSV Manager, Technical Engineering

View Profile
Florian Spribille
Florian Spribille

Senior Consultant Automation

View Profile
Klaus Finneiser
Klaus Finneiser

Freelancer

View Profile
Andreas Seidl
Andreas Seidl

Interim Head of Risk Management and Usability

View Profile
Stefan Schotte
Stefan Schotte

Interim Manager Project Management PMO

View Profile
Burcu Passiz
Burcu Passiz

QA Validation/Qualification (BioNTech)

View Profile
Hans Spichiger
Hans Spichiger

Interim Manager, Consultant, Facilitator

View Profile
FRATCH Nebe
FRATCH Nebe

Sterbfritz Plant Technical Manager

View Profile
Oliver Wulf
Oliver Wulf

Specialist Planner / Cleanroom Planning Lead

View Profile
Timur Güvercinci
Timur Güvercinci

Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

View Profile
Klaus-dieter Bleuel
Klaus-dieter Bleuel

Site Manager Lithium-Ion Battery

View Profile
Jürgen Schmickler
Jürgen Schmickler

Manager Manufacturing Operations USP

View Profile
Holger Beck
Holger Beck

Consultant for development-related topics and standards

View Profile
Rüdiger Schüller
Rüdiger Schüller

Interim Manager / Self-employed Engineer

View Profile
Johannes Fruntzek
Johannes Fruntzek

Material Handling Project Management

View Profile
Elena Chis
Elena Chis

Plant Quality Manager

View Profile
Manuel Eckhardt
Manuel Eckhardt

Freelance Engineer

View Profile
Gerd Gembatzke
Gerd Gembatzke

Head of Quality Management and QM Taskforce

View Profile
Kai Jeske
Kai Jeske

Freelancer / QM Consultant

View Profile
Cemil Sansak
Cemil Sansak

Configuration management support, change request and defect management

View Profile
Isaac Udoh
Isaac Udoh

Global Head of Quality, Safety and Regulatory Affairs

View Profile
Norbert Helmke
Norbert Helmke

Interim Project Manager Ramp-Up Pilot Facility

View Profile
Frank Doerries
Frank Doerries

Project management, development and system integration for the retrofit of a Uranus thermionic mass spectrometer

View Profile
Ashwini Reddy kapu
Ashwini Reddy kapu

Technical Analyst

View Profile
Manuel Kathofer
Manuel Kathofer

Overall Project Manager for the Global Roll-Out of a Quality and Document Management System

View Profile
Merve Gürbüz bozkurt
Merve Gürbüz bozkurt

Qualified Person

View Profile
Fabian Schnell
Fabian Schnell

Project Manager and Quality Specialist

View Profile
Estelle Kamwa
Estelle Kamwa

Document Management / Document Controlling Specialist

View Profile