V.I.E Qualification & Validation engineer (M/F)

  • Temps complet
  • Contract Type: VIE

Description de l'entreprise

ALTEN is a world leader in Engineering and Technology Consulting with almost 60 000 employees, 88% of whom are engineers. Operating in more than 30 countries, the Group supports its customers' development strategy in the areas of engineering, innovation, R&D and technological information systems.

Why choose ALTEN?

  •  It is a great opportunity to take part in the greatest technological challenges
  •  Working in a collaborative work environment provides close support
  •  We are a real career booster in France and abroad

Description du poste

As a Qualification and Validation Consultant, your expertise will support the projects of our partners whose activities are established in the production of medicines or health-related products.

You will play a central role in coordinating and executing the validation cycle with the aim of successfully completing projects within the given timelines. To do so, you will:

  • Represent the Validation department on various projects;
  • Design and implement the best Validation strategy;
  • Coordinate project planning with all stakeholders (Production / QA / Maintenance);
  • Participate in risk assessment through the drafting of a "Risk Assessment";
  • Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS);
  • Write protocols, coordinate, and ensure the proper execution of tests (URS / FAT / SAT / IQ / OQ / PQ);
  • Analyze and interpret results in order to draft the corresponding reports;
  • Develop training sessions and coach operators in the field;
  • Manage deviations related to validation runs and implement the associated CAPAs.

Qualifications

  • A degree in Engineering, a Master’s in Bioengineering, Industrial Pharmacy, or related fields;
  • Experience in qualification and validation within a GMP environment;
  • Knowledge of production processes in the pharmaceutical industry;
  • The ability to work in English as well as French.
  • Curious to learn more about production equipment and/or manufacturing processes;
  • Organized and meticulous in drafting your GMP documentation;
  • Communicative and enjoy interacting with various departments such as Production / Quality Assurance / Maintenance.

Informations complémentaires

ALTEN's Commitment

Our three pillars of commitment to sustainability:

  • People: We celebrate the richness of our diverse workforce, representing over 100 nationalities. Our commitment is to cultivate an inclusive environment where everyone can grow and make meaningful contributions. We support skill acquisition and actively assist our talents in their personal and professional development.
  • Environment: Our mission is to minimize our environmental impact by promoting sustainable growth. We are committed to achieving net-zero emissions by 2050, a goal that guides our operations and strategic initiatives.
  • Sustainable Innovation: At ALTEN, we view sustainability challenges as opportunities to drive research and innovation. With 31% of our internal R&D focused on sustainable innovation, we are determined to transform these challenges into solutions that create value and drive progress.

 

Ready to take on the challenge? Apply now and embark on a career where every project is an opportunity to learn, innovate, and thrive!

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