Maintenance Engineer – Quality (GMP)

Johnson & Johnson Co.; Leiden; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

36 vacation days (full-time)

Discount on health and wellness perks

Professional development opportunities

Job summary

Johnson & Johnson Innovative Medicine in Leiden seeks a Maintenance Engineer - Quality to bridge Maintenance and Quality. You will lead and facilitate GMP investigations of equipment, utilities and maintenance processes to improve CAPAs, reduce delays and strengthen compliance.

In collaboration with Maintenance, Engineering, Quality and production, you will ensure robust root-cause analysis, CAPA effectiveness and compliant reporting within a GMP-regulated environment.

Qualifications

• Bachelor or HBO diploma in a technical discipline.
• Minimum five years in Maintenance, Engineering, Reliability or Technical Operations.
• Experience in GMP-regulated pharmaceutical or biotech environments.
• Proven experience with technical investigations and root cause analyses.
• Knowledge of maintenance processes and asset lifecycle management.
• Strong technical writing, analytical and facilitation skills.
• Ability to interpret technical data and maintenance history.
• Experience with SAP or CMMS systems; familiarity with reliability methods (RCM/FMECA) is a plus.

Responsibilities

• Lead and facilitate technical investigations and GMP deviations related to equipment, utilities and maintenance activities.
• Perform structured Root Cause Analyses using methods like 5 Why, Fishbone, Event Mapping.
• Translate technical findings into GMP-compliant investigation reports.
• Conduct impact analyses on product, process and compliance.
• Define effective CAPAs addressing root causes and preventing recurrence.
• Monitor CAPA implementation and effectiveness.
• Provide technical input for Change Controls, Risk Assessments and Quality Records.
• Identify recurring problems and trends needing corrective actions.
• Support audit and inspection readiness; promote standardization and continuous improvement.

Skills

Analytical Reasoning

Audit Management

Calibration Procedures

Critical Thinking

Data Reporting

Engineering

Equipment Maintenance

Execution Focus

Lean Supply Chain

Mechanical Equipment

Quality Validation

Repair Management

Systems Evaluation

Technical Credibility

STEM Application

Education

Bachelor or HBO diploma in Mechanical Engineering, Electrical Engineering, Process Technology, Industrial Engineering, or similar technical field

Tools

SAP

Job description

Johnson & Johnson Innovative Medicine in Leiden seeks a Maintenance Engineer - Quality to bridge Maintenance and Quality. You will lead and facilitate GMP investigations of equipment, utilities and maintenance processes to improve CAPAs, reduce delays and strengthen compliance.

In collaboration with Maintenance, Engineering, Quality and production, you will ensure robust root-cause analysis, CAPA effectiveness and compliant reporting within a GMP-regulated environment.