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Engineer computer system validation (Entry level - senior)

Auris Health

Auris Health

2440 Geel, Belgium
Posted on Monday, September 4, 2023
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Description

Janssen Pharmaceutica is recruiting for a  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

CSV Engineer is an exciting role with a large degree of scope and autonomy where you will act as domain expert for computer system validation and data integrity. You play a key role in projects ensuring the validation approach and a fit for purpose in a quick changing world of automatization and AI. You will work in close partnership with Operations, Engineering, Quality, Maintenance and EH&S departments. Next to projects, you will act CSV spokesperson during regulatory and client quality audits, communicating the computer system validation approach and status of our MAKE assets and process control systems.

Based on your expertise, you drive continuous improvement related to CSV and data integrity processes, methodologies, and tools, and will act as mentor for external CSV engineers.

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

Qualifications

Who we’re looking for:

  • Entry-level candidates with an educational background in  industrial pharmacy, electromechanical engineering, automation, chemistry, bio engineering, life sciences.... will be considered as well as experienced candidates
  • You have a passion for CSV and data integrity engineering.

  • You love working in a team, hearing different point-of-views, and discussing them with your peers.

  • 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.

The successful candidate will have experience, skills, and a track record of achievement in the following:

  • Understanding of GAMP & CSV and data integrity, guidelines, and regulations

  • Strong affinity with CSV for process control systems ,equipment, production systems, utilities, and facilities

  • Candidates can operate both strategically/conceptually and connect easily across different levels in the organization (locally and globally at a Platform level).

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