Commissioning and Qualification Lead

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 https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
People Leader

All Job Posting Locations:
Beerse, Antwerp, Belgium, Geel, Antwerp, Belgium

Job Description:

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

The Chemical Development Pilot Plants at the Geel and Beerse sites; and our Commercial API (Active Pharmaceutical Ingredient) Plants at the Geel site 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
 

Key Responsibilities

As a C&Q lead 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.

Your role will include:



* Being the primary accountable person for all C&Q related life cycle activities for our process equipment (new and existing process installations) and automation systems


* Leadership of the GET qualification team


* Set up the strategic direction and manage our external service providers for equipment and CSV qualification


* Being overall accountable for the transition of our qualification approach from V-model to Risk Based Approach; based on the JNJ global procedures; both for legacy systems and new process installations; including the development and reporting on metrics for the transition plan.


* Set the qualification strategy in Capital projects (yearly portfolio 80 million eu...