Device Packaging Ops Investigator & CAPA Lead

Johnson & Johnson MedTech; Beerse; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation and leave benefits

Job summary

Johnson & Johnson is seeking a Manufacturing Operations Support Specialist based in Beerse, Belgium. You will lead investigations into deviations in device assembly and packaging, coordinating with QA, Engineering and MSAT to ensure product quality and patient safety.

The role requires a strong background in regulated manufacturing, cGMP, and data integrity, with excellent English communication and collaboration skills; Dutch is an asset for site collaboration.

Qualifications

• Bachelor’s or Master’s degree in engineering, pharmaceutical sciences, life sciences, chemistry, or equivalent relevant experience.
• Experience in pharmaceutical manufacturing, medical devices, or packaging in a regulated environment.
• Strong knowledge of cGMP and data integrity principles.
• Experience with deviation management, root cause analysis, risk assessment, and CAPA.
• Familiarity with automated production equipment and vision/inspection systems.
• Strong analytical and communication skills; English required; Dutch a plus.

Responsibilities

• Lead investigations into deviations, incidents, and complaints in device assembly and packaging and deliver corrective actions.
• Analyze batch records, equipment data, vision outputs, alarms, and yield trends for impact assessment.
• Define and drive corrective and preventive actions with QA, Engineering and Maintenance.
• Prepare cgMP-compliant investigation reports and support risk assessment and CAPA governance.
• Turn findings into durable improvements: standard work, training, procedures and preventive controls.
• Coach operators on investigation quality and documentation; participate in cross-functional reviews and audits.

Skills

Analytical skills

Collaboration

English proficiency

Education

Bachelor’s or Master’s degree in engineering or life sciences

Tools

Automated production equipment

Vision/inspection systems

Job description

Johnson & Johnson is seeking a Manufacturing Operations Support Specialist based in Beerse, Belgium. You will lead investigations into deviations in device assembly and packaging, coordinating with QA, Engineering and MSAT to ensure product quality and patient safety.

The role requires a strong background in regulated manufacturing, cGMP, and data integrity, with excellent English communication and collaboration skills; Dutch is an asset for site collaboration.