Pilot Plant Quality & Compliance Engineer (Pharma)

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Vor Ort; EUR 60.000 - 96.000; Vollzeit

Benefits dieser Stelle

Challenging international role

Continuous learning and career growth

Hospital insurance and healthcare

Inclusive workplace and work-life-bala

Zusammenfassung

Johnson & Johnson’s Belgian campus in Beerse and Geel seeks a Quality and Compliance Engineer to support day-to-day pilot-plant operations, coordinate deviations, and ensure regulatory compliance for APIs during clinical development. The role emphasizes phase-appropriate quality practices and cross-functional collaboration with operations, maintenance, and QA.

Responsibilities include leading deviation investigations, cleaning validation support, and lifecycle management of systems, with a

Qualifikationen

• A PhD or master’s degree in chemistry, chemical engineering, or a related field, or relevant experience in the pharmaceutical industry.
• Practical knowledge of current Good Manufacturing Practices and ICH Q7 is an asset.
• Understanding of process safety, pilot plant operations, process development, and engineering.

Aufgaben

• Support pilot plant operations and the timely release of clinical batches and equipment.
• Coordinate and document deviation investigations.
• Facilitate root-cause analysis and the definition of corrective and preventive actions.
• Assess the impact of deviations on product quality and regulatory compliance.
• Support cleaning-limit calculations, cleaning validation, and the improvement of cleaning methods.
• Implement projects that maintain the compliance of pilot plant systems with evolving regulatory requirements.
• Contribute to lifecycle-management activities for systems including deviation management, equipment qualification, cleaning validation, and contamination control.
• Work closely with operations, engineering, maintenance, and Quality Assurance.

Kenntnisse

PhD/MSc in chemistry/chemical eng

GMP & ICH Q7

Process safety

Pilot plant operations

Analytical thinking

Communication & collaboration

Project management

Ausbildung

PhD or MSc in chemistry/chemical engineering

Jobbeschreibung

Johnson & Johnson’s Belgian campus in Beerse and Geel seeks a Quality and Compliance Engineer to support day-to-day pilot-plant operations, coordinate deviations, and ensure regulatory compliance for APIs during clinical development. The role emphasizes phase-appropriate quality practices and cross-functional collaboration with operations, maintenance, and QA.

Responsibilities include leading deviation investigations, cleaning validation support, and lifecycle management of systems, with a