Device Packaging Operations Specialist — CAPA & Investigations

jj

Beerse

On-site

EUR 60,000 - 75,000

Full time

5 days ago

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Job summary

Johnson & Johnson Beerse site is seeking a Manufacturing Operations Support Specialist to join the Device Assembly & Packaging team. You will lead investigations into deviations and incidents, analyze data, and drive CAPAs with QA, Engineering and Maintenance to ensure product quality and patient safety.

You'll develop and implement corrective actions, strengthen standard work, and mentor operators on problem-solving with cross-functional teams.

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 regulated environments.
Strong knowledge of cGMP, data integrity, deviation management, root cause analysis, risk assessment and CAPA.
English proficiency; Dutch is an asset for site collaboration.

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 and prevent recurrence.
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; participate in cross-functional reviews and audits.