Hayat Bouknine-Qualification & Validation Engineer – Equipment and Utilities
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Experience
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.
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.
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.
Qualification/Validation Consultant
SANOFI
- Led technical meetings and managed scheduling.
- Developed URS and IQ/OQ/PQ protocols and reports.
- Qualified cold rooms.
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).
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.
Filling Line Leader – Sterile Production
ASPEN
Production Support Technician
SANOFI
Visual Inspection Line Operator
SANOFI
Pharmaceutical Technical Assistant
Apotheke
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Pharmaceutical, Healthcare, and Manufacturing.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Customer Service, Quality Assurance, Production, and 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
Education
TSPCI · Pharmaceutical and Cosmetic Industry
BP – PTA · PTA
Bachelor in Biology · Biology
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Hayat is based in Sankt Johann, Germany.
Hayat speaks the following languages: French (Native), English (Advanced), German (Elementary).
Hayat has at least 16 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 7 months. Note that Hayat may not have shared all experience and actually has more experience.
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.
Hayat's most recent position is Qualification & Validation Engineer – Equipment and Utilities at SOPHARTEX.
In recent years, Hayat has worked for SOPHARTEX, CURIUM, APTAR, SANOFI, and GSK.
Hayat is most experienced in industries like Pharmaceutical, Healthcare, and Manufacturing.
Hayat is most experienced in business areas like Customer Service, Quality Assurance, and Production. Hayat also has some experience in Operations.
Hayat has recently worked in industries like Pharmaceutical and Manufacturing.
Hayat has recently worked in business areas like Quality Assurance, Production, and Operations.
Hayat holds a Bachelor in Biology.
The availability of Hayat needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 26 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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