Quality Assurance EM/Sterility Engineer

Who we are

At Capgemini Engineering we value excellence, care, responsibility, dynamism, and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.

If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!

Your role

  • You will manage and execute continuous improvement projects or remediations plans to sterility assurance (incl. change control management, SOP’s review);
  • You will manage relationship with aseptic operations;
  • You will identify potential quality and compliance risks and help to manage these risks through the existing quality systems;
  • You will perform gap analysis, system effectiveness reviews and other management reviews;
  • You will guarantee the maintenance of the GMPs in responsibility (SOP, documentation, audits, training, method validation);
  • You will ensure and support the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring;
  • You will contribute to intern QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks.

Your profile

  • Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related domains,
  • Fluent in French or Dutch and proficiency level in English,
  • A previous experience in the (bio)pharmaceuticals, medical devices, or biotechnology sector
  • A relevant experience of minimum 2 years in sterility assurance
  • Knowledge of GxP
  • Hands-on approach, able to work on the shop floor, coaching and mentoring style, strong communication skills

Ref:

137045

Posted on:

July 4, 2022

Experience level:

Experienced

Contract type:

Full-time