Manufacturing Ops Specialist: CAPA & Quality Investigations

Brighter Signals; Beerse; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson in Beerse is seeking a Manufacturing Operations Support Specialist to join the Device Assembly & Packaging team. You will lead investigations, analyze data, and implement corrective actions to protect product quality and patient safety in a cross-functional setting.

Fluency in English is required; Dutch is a plus. A Bachelor’s or Master’s degree in engineering or related field and experience in regulated manufacturing are strongly preferred.

Qualifications

• Bachelor’s or Master’s degree in engineering, pharmaceutical sciences, life sciences, chemistry, or equivalent relevant experience.
• Experience in pharmaceutical manufacturing, medical devices, packaging or investigations in a regulated environment.
• Strong knowledge of cGMP, data integrity, deviation management, root cause analysis, risk assessment and CAPA principles.

Responsibilities

• Lead end-to-end investigations into deviations, incidents and complaints in device assembly and packaging.
• Analyze batch records, equipment data, vision/inspection outputs, alarms and yield trends.
• Define and drive CAPAs with QA, Engineering and Maintenance to restore reliability.
• Prepare cgMP-compliant investigation reports and support risk assessment, product disposition and CAPA governance.
• Turn investigation findings into durable improvements: standard work, training, procedures and preventive controls.
• Coach operators on investigation quality and problem solving; represent Operations in cross-functional reviews and audits.

Skills

Analytical reasoning

Coaching

Communication

GMP

Lean manufacturing

MSAT

Manufacturing Engineering

Project Engineering

Report Writing

Safety

STEM

Education

Bachelor’s or Master’s degree in engineering

Tools

Automated production equipment

Vision systems

Packaging materials

Job description

Johnson & Johnson in Beerse is seeking a Manufacturing Operations Support Specialist to join the Device Assembly & Packaging team. You will lead investigations, analyze data, and implement corrective actions to protect product quality and patient safety in a cross-functional setting.

Fluency in English is required; Dutch is a plus. A Bachelor’s or Master’s degree in engineering or related field and experience in regulated manufacturing are strongly preferred.