Commissioning and Qualification Engineering 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 jnj.com.

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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Project Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Geel, Antwerp, Belgium

Job Description:

Johnson and Johnson is recruiting for a Commissioning and Qualification Engineering 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 professional colleagues who share a ‘can do’ mentality. 
  

Key Responsibilities 
  

As a C&Q Engineering lead in GET your primary objective is to provide direction and expertise for Compliance 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 compliance team 

• Set up the strategic direction and manage our external service providers for equipment and Computer System Validation (CSV) 

• 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 100 million euro CAPEX investments) 

• Act as spokesperson for GET during regulatory inspections and client audits; including the preparation of the audit; together with regulatory compliance and QA. 

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

• Keep up to date with the equipment and CSV qualification standard processes 
    

Qualifications, Experience and Skills: 

• A Master’s degree or equivalent experience; preferable in a Chemical Science; Technology or Engineering Field. 

• Experienced people leader. 

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

• An individual who feels that safety and quality is of a paramount importance 

• 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. 
    

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. 

#SCQuality

#LI-BM5

 

 

Required Skills:

 

 

Preferred Skills:

Agile Decision Making, Budget Management, Coaching, Collaboration, Critical Thinking, Customer Centricity, Knowledge Networks, Lean Supply Chain Management, Organizational Project Management, Organizing, Project Engineering, Quality Assurance (QA), Regulatory Compliance, Resource Forecasting, Science, Technology, Engineering, and Math (STEM) Application, Scientific Research, Strategic Supply Chain Management

  

 

The anticipated base pay range for this position is:

€79,800.00 - €137,770.00

 

 

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

 

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.