Commissioning and Qualification Engineering Lead

Johnson and Johnson is recruiting foraCommissioning 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 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 youll collaborate withprofessionalcolleagues who share a can do mentality.

Key Responsibilities

As a C&QEngineeringlead in GET your primary objective is to provide direction and expertise for Complianceand qualification initiatives of strategic importance supporting our Current products and new Product Introductions in Beerse and 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 GETcomplianceteam

• Set up the strategic direction and manage our external service providers for equipment and ComputerSystemValidation (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 portfolio100million euroCAPEX 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 Masters 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 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.