Maintenance Engineer - Quality, GMP, 12-Month Contract

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson is seeking a Maintenance Engineer - Quality for its GET Maintenance team in Leiden. You will bridge Maintenance and Quality, leading investigations on equipment, utilities and maintenance processes to ensure GMP compliance.

You will perform root cause analyses, define CAPAs, and provide technical input for Change Controls and Quality Records, helping to shorten investigation cycle times and improve reliability.

Qualifications

• Bachelor's or HBO degree in mechanical/industrial engineering or related technical field.
• Minimum five years of experience in Maintenance, Engineering, Reliability or Technical Operations.
• Experience in a GMP-regulated pharmaceutical/biotechnological setting.
• Demonstrated experience with technical investigations, deviations and Root Cause Analysis.
• Knowledge of maintenance processes, asset lifecycle management and reliability principles.
• Strong skills in technical writing, analysis and facilitation.
• Ability to interpret technical data, maintenance history and system performance.
• Experience with SAP or a similar maintenance management system.

Responsibilities

• Lead and facilitate technical investigations and GMP deviations related to equipment, utilities and maintenance activities.
• Perform structured Root Cause Analyses using 5 Why, Fishbone Analysis, Event Mapping.
• Translate technical findings into clear GMP-compliant investigation reports.
• Conduct impact analyses on product, process and compliance.
• Define effective CAPAs to address root causes and prevent recurrence.
• Monitor implementation and effectiveness of CAPAs.
• Provide technical input for Change Controls, Risk Assessments and Quality Records.
• Identify recurring issues and broader corrective actions.
• Support audit and inspection readiness.
• Promote standardization and continuous improvement of investigation methodologies within GET Maintenance.

Skills

Analytical Reasoning

Root Cause Analysis

Technical Writing

Data Reporting

Maintenance Engineering

Equipment Maintenance

Reliability Principles

Communication

SAP

Education

Bachelor's or HBO in Mechanical Engineering

Experience in GMP-regulated environment

Tools

SAP

CMMS

Job description

Johnson & Johnson is seeking a Maintenance Engineer - Quality for its GET Maintenance team in Leiden. You will bridge Maintenance and Quality, leading investigations on equipment, utilities and maintenance processes to ensure GMP compliance.

You will perform root cause analyses, define CAPAs, and provide technical input for Change Controls and Quality Records, helping to shorten investigation cycle times and improve reliability.