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Bilal YoussfiBY

Bilal Youssfi

Process Automation / CQV Engineer

€450/day
Lyon, FR
3-7 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Bilal

My training in process engineering has allowed me to develop a deep understanding of this multidisciplinary field, at the interface between science, engineering, and industrial operation. I have thus evolved in demanding environments, particularly in CQV (Commissioning, Qualification, Validation), automation, and regulated contexts such as the pharmaceutical industry, where rigor, traceability, and compliance are essential. This experience is based on a strong field presence, close to the facilities and teams.
Accustomed to intervening directly on site, I adopt a pragmatic approach focused on troubleshooting, failure analysis, and system requalification. I can quickly diagnose, structure investigations, and propose robust solutions, especially during the critical phases of commissioning, qualification, or operation.
My background gives me a versatile profile. Thanks to a dual expertise in product/equipment and chemistry/biology, enhanced by mastery of automated systems and validation requirements, I can address a wide range of industrial issues: commissioning, ramp-up, process optimization, and continuous improvement. This adaptability allows me to intervene in the pharmaceutical sector as well as in other process industries (energy, chemistry, agri-food, etc.).
Driven by a culture of problem-solving and results, I also promote knowledge sharing and collaboration, contributing to a collective dynamic of sustainable learning and progress.
  • French

    Native or bilingual

  • English

    Fluent

  • Spanish

    Conversational

Can work on-site
Lyon (up to 50km)

Experience

  • Boehringer Ingelheim
    Process CQV Engineer
    PHARMACEUTICALS INDUSTRY
    May 2024 - May 2026 (2 years)
    Lyon, France
    Context: The Antares project, a major industrial initiative led by the pharmaceutical laboratory Boehringer Ingelheim, aims to build a state-of-the-art multi-vaccine biotechnological production site. This new site will enable the development and production of innovative vaccines for combating animal diseases.
    With an investment of 600 million euros, this project illustrates Boehringer Ingelheim's commitment to innovation and animal health on a global scale.

    Mission Details:
    In this mission, I am in charge of the commissioning of the upstream part (Bioreactor, Sterilizing Filter, Sedimentation Tank, Medium Preparation Tank) and the downstream part (centrifuge, chromatography, UF...).

    . Review of automation functional specifications to ensure compliance with the client's URS and suitability for producer needs
    • Coordination and execution of FAT (tests in a simulator) and SAT (on-site tests)
    • Coordination and execution of commissioning tests
    . Automation and Instrumentation: Loop check, Control Module, Control Module Equipment, Regulation, PID Tuning, Phase, Operation, Sub-Procedure, Procedure
    . Mechanical-chemical: Regulator adjustment, definition of CIP solution conductivity and concentration, transfer pressure adjustment, biosafety, production pressure and temperature, performance testing, technical batch...
    • Production functions: Leak testing, Sterilization (tank, line, filter...), inter-equipment and inter-workshop transfer (Sending, Receiving... ), Production functions (Cell Culture,
    Sedimentation...)
    • Troubleshooting of process control systems and management of deviations and change controls

    • Qualification
    -IQ, OQ
    -Participation in protocol drafting, review, and approval
    -Execution of tests and management of non-conformities
    -Coordination with stakeholders (Quality, Producer, Supplier, Maintenance...)
    Commissioning Automation Qualification Configuration Troubleshooting
  • SEQENS
    CQV Engineer
    PHARMACEUTICALS INDUSTRY
    November 2023 - April 2024 (5 months)
    Aramon, France
    Context: As part of the France Relance plan. The CDMO SEQENS is expanding its production site with a new production workshop consisting of 5 reactors and 1 filter dryer for the production of APIs in powder form. Part of the site is being revamped, and new equipment is being purchased.

    Mission Details:

    In this mission, I am in charge of:

    • Commissioning:
    - FAT/SAT testing with the supplier to ensure the correct installation of the equipment in compliance with site requirements and the specifications (URS).
    . Automation testing:
    - Loop check, equipment module testing, interlocks, cause-and-effect matrix, regulation (PID tuning).
    - Review of FSDS and point of contact between operators and the automation team.
    - FAT in shadow unit.
    - SAT on the equipment.
    . Process tuning on equipment (switchover threshold, drop tail, flow rate, pump power...).
    . Process risk analysis and implementation in the SCADA safety matrix.
    . Point of contact with suppliers and external contractors to repair or improve equipment to ensure the most optimal future production startup.
    • Qualification
    -Coordination of on-site execution of (QI, QO, QP) protocols with the teams (Production Equipment and Utilities).
    - Report writing.
    - Initiation of deviations and CCs in case of discrepancies.
    - Management of unforeseen issues.
    - Management of materials and labor.
    • Validation
    - Adaptation of the SCADA to different future processes.
    - Cleaning validation.
    Automation Commissioning Qualification Troubleshooting SCADA
  • Boehringer Ingelheim
    VIE Operational Excellence Maintenance
    PHARMACEUTICALS INDUSTRY
    November 2022 - November 2023 (1 year)
    Guildford, United Kingdom
    Context:
    Pharmaceutical industry, producing animal vaccines against FMD virus. Mission within the maintenance department. Participation in the implementation of a new CMMS and criticality analysis of the site's equipment fleet. As well as the commissioning of measurement equipment following the criticality analysis.

    Mission Details:

    • Commissioning of measurement equipment:
    o UV Analyzer: Drafting of an installation procedure for a UV analyzer as well as troubleshooting, calibration, and maintenance checks. Purchase of calibration and maintenance kits to internalize certain preventive maintenance operations.
    o Weighing cell: Transition from an analog system to a digital system. Work with suppliers for quotes, plans, and coordination with field technicians for the installation of the measurement loop and troubleshooting of the measurement loop.
    o Differential pressure sensor: Installation of a digital system.

    • Support for the implementation of a CMMS system on site:
    o Work with global teams to understand the system's operation and implementation steps and monitor software updates.
    • Criticality Analysis:
    o Facilitation of cross-functional working groups (Quality, Validation, Production, Maintenance, Engineering) to perform a process criticality analysis for the implementation of preventive and corrective maintenance for the various measurement chains.

    • Coordination of preventive and corrective maintenance:
    o Management of investigations and CAPAs for non-conformities as well as change controls in case of changes or commissioning.
    o Coordination of shutdown activities.
    o Interaction with external contractors for commissioning, maintenance, and calibration.
    o Management of unforeseen events. Continuous improvement of processes.

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Education

  • Process and Bioprocess Engineering
    Polytech Nantes
    2022
    Ingénieur en génie des procédés et bioprocédés–
  • Risk Analysis Certification
    Certification analyse de risque

Categories

  • Other