Azidin Karayilan
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CQV engineer -
Kneat Expert
Stein, Aargau, Switzerland
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CQV EngineerLonzaDec 2025 - Current (11 months)Project #6- CQV EngineerLonzaJan 2025 - Dec 2025 (1 year)Project #4: Brownfield Project – Logistics Expansion o Led the revamping and expansion of a logistics area to improve efficiency, storage, and material flows. o Executed commissioning of equipment, HVAC, utilities, and classified rooms in line with GMP and project requirements. o Supported C&Q by performing tests, documenting results, and resolving deviations. o Worked with engineering, QA, automation, and construction teams to ensure smooth start-up and readiness. Project #5: Greenfield Project – Small Equipment o Executed commissioning C&Q activities for small equipment (including Single Use Mixers). o Provided technical expertise to resolve equipment integration and process challenges. o Collaborated with engineering, QA, automation, and
- TeilprojektleiterLonzaDec 2023 - Dec 2024 (1 year 1 month)Project #1: Greenflied project - Responsible of all process and support equipment (with a focus on Downstream Processing (DSP)), clean and black utilities, and clean room. o Reviewing and approving all design, C&Q documents related to process and support equipment, clean and black utilities, and cleanroom ensuring accuracy and compliance. o Supporting the C&Q activities. Project #2: Brownfield project Module Expansion: o Contributed to the design phase of a module expansion project to increase production capacity. o Managed the selection, integration, and implementation of all Material Handling equipment. o Modeled production processes to calculate the required number and type of equipment, ensuring optimal capacity utilization. o Worked on
- CQV Engineer for CRBLonzaMar 2023 - Dec 2023 (10 months)- Authored and executed key Commissioning and Qualification (C&Q) documents for various systems (Process, Utilities) using Kneat. o User Requirement Specifications (URS) and Technical Specifications (TS) o Design Review (DR) and Failure Modes and Effects Analysis (FMEA) o Verification Engineering Plans for URS compliance o Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and Commissioning documents o Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ)
- CQV Engineer for CRBTakedaOct 2022 - Mar 2023 (6 months)Project #1: Brownfield project The project aims to double production capacity by automating processes, utilizing machinery, sensors, and control systems. Two production lines will have modified pipework with automatic valves and instruments. Comprehensive design documentation, Commissioning Qualification documentation preparation will ensure safety, reliability, and quality compliance. - Procurement (choosing suppliers, interviewing them, negotiating, comparing offers, making recommendation) - URS (Utilities, System) - Verification Engineering Plan of URSs - Design Review/Design Qualification of URSs - SAT protocols (HVAC, Cleanroom-Doors-Ceiling-Interlock system,Utilities) Project #2: Brownfield project This project aims to replace existin
- PProcess Engineer for CRBAug 2022 - Sep 2022 (2 months)A feasibility study was conducted in establishing a cancer diagnosis facility. The study evaluated both the scientific and technological feasibility, as well as the logistical feasibility of the project. Operational costs, which included equipment, staff salaries, and facility rent, were analyzed to determine the financial feasibility of the project. The findings and recommendations provided the client with valuable insights into the potential risks, benefits, and costs associated with developing and launching the facility. - Identify the problem or opportunity - Assess market potential - Evaluate regulatory requirements - Evaluate technical feasibility - Determine financial viability - Identify potential partners - Conduct risk analysis -
- CQV EngineerCRBJul 2022 - Feb 2024 (1 year 8 months)For different clients in pharmaceutical area (Switzerland, Europe)
• Developing and implementing commissioning, qualification, and validation protocols and plans.
• Conducting risk assessments and reviewing design documents to ensure compliance with regulations and industry standards.
• Performing equipment and system qualification activities such as functional testing, performance testing, and process simulation.
• Collaborating with cross-functional teams, such as engineering, operations, and quality, to ensure that CQV activities are integrated into project schedules and budget.
• Writing and reviewing validation reports to ensure accuracy and completeness.
• Staying up-to-date with industry regulations and - CQV Engineer for CRBLonzaJul 2022 - Oct 2022 (4 months)- Authored and executed key Commissioning and Qualification (C&Q) documents for various systems (Process, Utilities) using Kneat. o User Requirement Specifications (URS) and Technical Specifications (TS) o Design Review (DR) and Failure Modes and Effects Analysis (FMEA) o Verification Engineering Plans for URS compliance o Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and Commissioning documents o Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ)
- Manufacturing EngineerMerck GroupSep 2021 - May 2022 (9 months)Improvement of the aseptic filling process (vial, syringe, cartridge) for the manufacturing of 4 drug products entities (Oncology, multiple-sclerosis, metabolism, fertility products) - Contribute to FDF technical projects, equipment, and process development. o Draft operational documentation and optimize existing processes (43% increase in on-time batch record delivery through lean 6 sigma). - Manage aseptic deviations, CAPA, Change Control: o Handle non-conformities and quality actions per procedures. o Collaborate with QA, QC, Technical Service, Warehouse, Visual Control. o Conduct shop floor investigations, root cause analysis, and tests. - Provide production support for the aseptic department: o Review FDF production files for content c
- Process EngineerGivaudanSep 2020 - Feb 2021 (6 months)Process improvement in fragrance production at Givaudan's largest production site - Improvement of local process: Number of large batches produced increased by 16.1% without investment (win of about 30M CHF/y) o Application of Lean-6 Sigma concepts o Data analysis o Elaboration of new software: ✓ Calculate production time of a composition depending on its formula and complexity (92% of match between the model and the reality) ✓ Modelling the production scheduling ✓ Reveal some non-productive times in the process ✓ Suggested a new way to work - Improvement of global and local process flow with worldwide stakeholders: o Participated to a new global process improvement project for the Vernier’s site ✓ Process validation ✓ Tested the feasibilit
Education
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- EPFL — Master's degree Chemical engineering and biotechnologyEPFLJan 2019 - Dec 2021 (3 years)The master of Science in chemical engineering and biotechnology enables to acquire a foundation in chemical engineering, management and safety of chemical processes, technology and process development, energy and environment, green chemical engineering, food science and polymer science. The programme combines lectures and exercices, lab works and projects, an internship in an industry and a thesis. Master thesis on management of nanomaterial hazards, supervised by MER Dr. Thierry Meyer and Dr. Elina Buitrago.
- EPFL — Admission year Chemical engineering and biotechnologyEPFLJan 2018 - Dec 2019 (2 years)All engineering courses of the Bachelor of Chemistry and Chemical Engineering have been completed.
- University of Geneva — Bachelor's degree ChemistryUniversity of GenevaJan 2015 - Dec 2018 (4 years)The bachelor of Science in chemistry enables to acquire a foundation in molecular and biomolecular sciences, in the field of analytical chemistry, bioorganic chemistry, materials science, solid state chemistry, inorganic chemistry, organic chemistry, polymer chemistry, physical chemistry, spectroscopy and biochemistry. The programme combines lectures and exercices, lab works and a thesis. Bachelor thesis on vibrational optical activity of VCD (Vibrational circular dichroism) & ROA (Raman optical activity) spectroscopies, supervised by Dr. Thomas Bürgi.