C&Q engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Johnson and Johnson is recruiting for a C&Q Engineer within Global Engineering and Technology (GET) in Geel/Beerse, Belgium.
 

Our Commercial API (Active Pharmaceutical Ingredient) Plants at the Geel site, together with our Chemical Development Plants in Geel and Beerse are important in driving forward the development of new medicines. Our primary goal is to ensure the safe, efficient, and competitive delivery of lifesaving medications to patients at all times. In addition to scaling up Active Pharmaceutical Ingredients (APIs) from lab scale to commercial production, the pilot plants and commercial plants also play a significant role in supplying medicines necessary for vital clinical studies before a product launch. To fulfill our mission, we consistently invest in ground breaking technologies, dedicated individuals, and strategic partnerships.

Our teams are working together in a dynamic environment where your contributions will be valued, and you'll collaborate with hardworking colleagues who share a 'can do' mentality
 

As a C&Q Engineer in GET your primary objective is to provide direction and expertise for Commissioning and qualification initiatives of strategic importance supporting our Current products and new Product Introductions in Beerse and Geel. In pursuit of this goal, close collaboration with the Operations, Maintenance, Quality, Safety, Clinical Development and Supply (CDS) and New Product Introduction (NPI) departments will be important.
 

• Being the domain expert of commissioning and qualification

• Guiding project teams in the application of Risk Based qualification; so the project teams can successfully introduce new equipment on site; aligned with our internal standards; quality requirements and regulatory expectations

• You are owner of the local qualification processes and can provide mentorship and training to internal and external team members to successfully apply these processes

• Act as spokesperson during regulatory inspections and client audits; including the preparation of the audit.

• Be an active member within the JNJ community of practice in Risk Based Qualification Approach
   

• Deep understanding of both FDA and EMA requirements towards equipment qualification, and industry standards like ICH Q7a, ISPE C&Q guidelines, GAMP5 and ASTM E2500 standard.

• Preferably hands-on experience in leading the execution of commissioning and qualification activities in projects

• Through your communication and social skills work together as a standout colleague, contributing to an energetic work environment in all levels of the organization.

• Proficient in Dutch (or willing to learn Dutch) and English

• You acquired a master's degree or equal trough experience. Preferred fields of study are Engineering or Science.
   

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.

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