Lead engineer computer system validation

Auris Health

Auris Health

2440 Geel, Belgium
Posted on Thursday, August 24, 2023
Apply Now


Janssen Pharmaceutica is recruiting for a principal / lead computer system validation (CSV) Engineer within the MAKE Asset Management (MAM) organization. The position will be based in Geel, Belgium. 

At Janssen Pharmaceutica, part of Johnson & Johnson, the world’s largest and most broadly based healthcare company, we set ourselves the goal to strive for a future in which disease is a thing of the past. For decades, we have pioneered world-changing and mind-blowing solutions, always putting people first and remaining true to our Credo. Every day, our more than 130,000 employees across the world are blending heart, science, and resourcefulness to profoundly change the trajectory of health for humanity. With a reach of more than a billion people every day, there’s no limit to the impact you can make here.

The Geel site is the largest chemical production site for small molecule API (Active Pharmaceutical Ingredients) within the Janssen supply chain. We ensure lifesaving medicines reach the patient, safely, optimality, competitively, always. Beside production of API's, the site has a launch & grow mission for new pharmaceutical products. To accomplice this mission, we keep investing in new technologies, people, and partnerships. Our teams are working together in a dynamic environment where innovation and a 'can do' state of mind are common good.

The MAM organization operates as one integrated team in the delivery of Engineering and Maintenance activities.

Job summary

As a CSV engineer you are able to continuously shape and improve our computer system validation and data integrity approach. You will lead improvement initiatives related to CSV processes, methodologies, and tools. You will act as a mentor for our team of external CSV engineers as well as team-up with project teams to set out the CSV approach on our larger size projects, in close collaboration with our Operations, Engineering, Quality, Maintenance and EH&S departments.

During regulatory and client quality audits you will use your expertise to step up as a spokesperson, communicating the CSV approach and status of our MAKE assets.

The CSV Engineer is a member of the Geel MAKE Asset Management organization.


Experience and Skills:

The successful candidate will have, or is willing to build, experience, skills, and a track record of achievement in the following:

  • Understanding of GAMP & CSV and data integrity, guidelines, and regulations
  • Experience in GMP or GLP regulated environment
  • CSV (process control systems, equipment, production systems, utilities, and facilities)
  • Candidates can operate both strategically/conceptually and connect easily across different levels in the organization.  

Who we’re looking for:

  • A colleague with a strong hands-on mentality.
  • You have a passion for CSV and data integrity engineering.
  • An outstanding teammember. You love working in a team, hearing different point-of-views, and discussing them with your peers and by doing that come to a team supported solution.
  • An individual who feels that safety and quality is of paramount importance.
  • An individual with strong communicative and social skills who can communicate effectively with stakeholders across different levels of our organization.
  • You acquired a master’s degree or equal trough experience. Preferred fields of study are Engineering or Science.

What you can expect from us:

Employees are vital to our organization. You will be part of an enthusiastic team in an innovative environment that values personal and professional development. In this role, you will have the potential to transform both our business and your career. We encourage you to think big and go after your goals. Through on the job training, e-learning, various projects, and programs, we ensure personal growth by focusing on your talents and empower you to take control over your career and where it leads you.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. We value diversity and inclusion and strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential