Expleo Group

Qualification/Validation Expert

Brussels, Brussels, BE

8 days ago
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Summary

Expleo offers a unique offering of integrated engineering, quality and strategic consulting services for digital transformation. In a context of unprecedented technological acceleration, we are the trusted partner of innovating companies. We help them develop a competitive advantage and improve the daily lives of millions of people. Present in 30 countries and with 19,000 employees, we support our customers on a daily basis. As part of our teams, you will carry out various advisory and support missions with our clients.

What means joining Expleo?

  • Technical support in the field and continuing training via our technical experts
  • Human value among our employee
  • The diversity of our teams an increase on skills throughout your career
  • Work on large-scale projects

As part of the development of our activities in Belgium, Expleo is looking to grow and expand the teams and is looking for individuals with skills in validation & qualification.

What does it mean to be a Validation& Qualification Expert?

  • Follow and update as necessary a Commissioning and Qualification plan
  • Ensure coordination of CQV activities and achievements of agreed milestones
  • Update the C&Q governing documents as requested and necessary
  • Manage C&Q partner for all activities being into their scope (Design review, design qualification, IOC protocols, IOQ protocols)
  • Author Validation Plan/Report, and review other system deliverable such as URS, FS, CD/DS, IQ, OQ, PQ, FRA;
  • Participate in the qualification of system such as HVAC< Clean utilities, process or lap equipment
  • Manage the project validation team and its deliverables on the project ;
  • Participate in project risk management and in the preparation of GMP inspections/submissions

  • What is critical for the role?

    • Your academic background is related to engineering and life science
    • 5y+ years’ experience in the life science industry
    • Experience in areas as Validation and qualification
    • Good writing skills and ability to develop and execute DQ, FAT, SAT, OQ,PQ,IQ development of SOP’s
    • Experience performing in project teams and providing deliverables involving evaluation of IT quality and GxP issue in a FDA regulated environment
    • English and French advance level mandatory, Dutch would be a big plus.
    • Use of KNEAT tools is an advantage

    What is in for you?

    • Collaborative working environment -we stand shoulder to shoulder with out clients and our peers through good times and challenges
    • We empower all passionate technology-loving professionals by allowing them to expand their skills and take part in the inspiring projects
    • Expleo Academy- enables you to acquire and develop the right skills by delivering a suite of accredited training courses
    • Always working as one team, our people are not afraid to think big and challenge the status quo
    • 20+12 (40h week) days of vacation per year
    • A mobility budget that can be use towards your mobility or rent/mortgage
    • A flexible homeworking policy

    Who we are?

    In this ever-evolving world Expleo Belgium is an engineering and digital transformation game-changer player on the market. We are here to support our customers achieve the highest level of success in their automation, agility and sustainability journey. We all have the same goals and are self-motivated by the same drivers

    We are EXPLEO.

    ,,We are an equal opportunity employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age’’

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