Pilot Plant Quality & Compliance Engineer (Pharma API)

Johnson & Johnson Co.; Geel; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Hospital insurance

Healthcare benefits

Work-life balance

Job summary

Johnson & Johnson Innovative Medicine seeks a Pilot Plant Quality and Compliance Engineer for Belgium to support day-to-day pilot plant operations, deviations investigations, cleaning validation, and cross-functional collaboration with operations, process engineers, maintenance, and QA.

The role involves root-cause analysis, CAPA, and ensuring regulatory readiness while preventing cross-contamination through robust cleaning processes and lifecycle-management of systems.

Qualifications

• PhD or master's in chemistry, chemical engineering, or related pharma field.
• Knowledge of current Good Manufacturing Practices and ICH Q7 is a plus.
• Understanding of process safety, pilot plant operations, process development, and engineering.
• Strong analytical and problem-solving skills.
• Ability to challenge existing practices and identify improvements.
• Strong communication and collaboration skills.
• Project-management skills with multiple priorities.

Responsibilities

• Support pilot plant operations and timely release of clinical batches and equipment.
• Coordinate and document deviation investigations.
• Facilitate root-cause analysis and corrective/preventive actions.
• Assess impact of deviations on quality and regulatory compliance.
• Support cleaning-limit calculations, cleaning validation, and improving cleaning methods.
• Implement projects ensuring pilot plant systems stay compliant with evolving regulations.
• Contribute to lifecycle-management activities for systems including deviation management and equipment qualification.
• Collaborate with operations, engineering, maintenance, and QA.

Skills

Analytical thinking

Problem solving

Communication skills

Project management

Collaboration

Education

PhD or MSc in chemistry/chemical engineering

Job description

Johnson & Johnson Innovative Medicine seeks a Pilot Plant Quality and Compliance Engineer for Belgium to support day-to-day pilot plant operations, deviations investigations, cleaning validation, and cross-functional collaboration with operations, process engineers, maintenance, and QA.

The role involves root-cause analysis, CAPA, and ensuring regulatory readiness while preventing cross-contamination through robust cleaning processes and lifecycle-management of systems.