C&Q lead

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 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.

Preferred Skills:

Agile Decision Making, Budget Management, Coaching, Collaborating, 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

Hybrid Work