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Quality Assurance EM/Sterility Engineer
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Industry

Computer/IT Services

Category

Engineering

Experience

Experienced

Applications are considered on a rolling basis

Location: Belgium

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Contact Person
Jennifer Gbologan

Job Description

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
About the company

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 340,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.

Get the Future You Want | www.capgemini.com

I'm interested