Operations Support Specialist: CAPA & Quality Investigations

Johnson & Johnson MedTech; Beerse; On-site; EUR 52,000 - 78,000; Full time

Job summary

Johnson & Johnson in Beerse, Belgium, is seeking an Operations Support Specialist to lead investigations and drive corrective actions across Quality, Engineering, Manufacturing and suppliers. English required; Dutch is a plus. The role focuses on ensuring a compliant, steady supply through data-driven problem solving.

You will work in a cross-functional environment, aligning with QA for risk assessment and CAPA governance while documenting findings and improving standard work.

Qualifications

• Bachelor’s or Master’s degree in engineering, pharmaceutical sciences, life sciences, chemistry, or equivalent proven experience.
• Experience in pharmaceutical manufacturing, medical devices, combination products, packaging, quality, engineering, or formal investigations in regulated environments.
• Strong working knowledge of cGMP, data integrity, deviation management, root cause analysis, risk assessment, and CAPA methods.
• Familiarity with automated production equipment, vision/inspection systems, packaging materials, and manufacturing data; hands-on device/syringe/vial experience is a strong advantage.
• Analytical and structured thinker who turns complex technical data into clear, evidence-based conclusions and manages multiple investigations to deadline.
• Excellent collaborator and communicator who engages stakeholders across functions and sites; professional English required, Dutch is an asset.

Responsibilities

• Lead end-to-end investigations into deviations, incidents, complaints and recurring quality issues in device assembly and packaging to find facts and deliver clear outcomes.
• Analyze batch records, equipment data, alarms, yield and maintenance information to identify evidence-based root causes.
• Assess patient, product and compliance impact, recommend disposition decisions, and partner with QA for risk assessment and CAPA governance.
• Define and drive corrective and preventive actions, then translate findings into standard work, training and preventive controls to stop recurrence.
• Coordinate cross-functional investigations across components, syringes, vials, labels and packaging materials, and support supplier and complaint investigations.
• Prepare timely, cGMP-compliant investigation reports, support audit readiness, and coach teams on disciplined problem solving and good documentation.

Skills

Root Cause Analysis

CAPA Methods

Data Integrity

Problem Solving

Cross-functional Collaboration

Education

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

Tools

Automated Equipment

Vision Systems

Documentation Tools

Job description

Johnson & Johnson in Beerse, Belgium, is seeking an Operations Support Specialist to lead investigations and drive corrective actions across Quality, Engineering, Manufacturing and suppliers. English required; Dutch is a plus. The role focuses on ensuring a compliant, steady supply through data-driven problem solving.

You will work in a cross-functional environment, aligning with QA for risk assessment and CAPA governance while documenting findings and improving standard work.