Pilot Plant QA & Compliance Engineer – Pharma Scale-Up

Biopharma Asia; Antwerpen; Hybrid; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Hospital insurance

Healthcare-related benefits

Job summary

Johnson & Johnson in Belgium seeks a Pilot Plant Quality and Compliance Engineer to support day-to-day operations, deviations investigations, and regulatory compliance across Beerse and Geel pilot plants. You will lead cleaning validation, responsible for cross-functional actions, and work with quality, operations and engineering teams.

This two-year term role offers exposure to multi-product processes, GMP environments, and ongoing process improvements within Innovative Medicine and MedTech.

Qualifications

• PhD or master's in chemistry, chemical engineering, or related pharma field.
• GMP knowledge and ICH Q7 familiarity are assets.
• Understanding of process safety, pilot plant operations, process development, and engineering.
• Strong analytical and problem-solving capabilities.
• Ability to challenge practices and identify improvements.
• Strong communication and collaboration skills.
• Project management and ability to manage 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 define corrective and preventive actions.
• Assess impact of deviations on product quality and regulatory compliance.
• Support cleaning-limit calculations, cleaning validation, and improvement of cleaning methods.
• Implement projects to maintain 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.

Skills

Analytical skills

Problem solving

Communication & collaboration

Multitasking & project management

Education

PhD or MSc in Chemistry / Chemical Engineering

Tools

GMP knowledge

ICH Q7 knowledge

Job description

Johnson & Johnson in Belgium seeks a Pilot Plant Quality and Compliance Engineer to support day-to-day operations, deviations investigations, and regulatory compliance across Beerse and Geel pilot plants. You will lead cleaning validation, responsible for cross-functional actions, and work with quality, operations and engineering teams.

This two-year term role offers exposure to multi-product processes, GMP environments, and ongoing process improvements within Innovative Medicine and MedTech.