Mechanical Engineer vacatures in Leiden

Our client is an international biopharmaceutical organization committed to advancing healthcare through the development and production of vaccines and therapeutic solutions. To strengthen their Engineering, Validation, and Maintenance (EVM) division, they are seeking an experienced Senior Quality Engineer. In this key position, you will play an essential role in maintaining high-quality standards and supporting continuous improvement across technical, validation, and maintenance operations in a GMP-regulated environment.

Job Description
As a Senior Quality Engineer, you will act as the quality and compliance expert within the EVM department. You will ensure that all technical and validation activities meet strict GMP and regulatory requirements while driving continuous improvement and operational excellence across multiple teams. Working closely with engineering, maintenance, and compliance colleagues, you will provide guidance on quality standards, risk assessment, and process optimization.
This role involves developing and implementing effective quality systems, analyzing performance data, supporting audits, and ensuring that all operations run efficiently and within compliance boundaries. You will also take the lead in promoting lean principles and process excellence throughout the department, enabling teams to work more effectively and deliver consistent results.

Responsibilities

• Ensure that maintenance, engineering, and validation processes comply with GMP regulations and company quality standards
• Lead process improvement initiatives focused on operational efficiency and continuous improvement
• Act as subject matter expert for validation and qualification activities
• Coordinate and support internal process alignment across EVM sub-teams
• Apply process excellence methodologies such as Lean Six Sigma to optimize workflows
• Develop and maintain performance metrics and reporting tools to track departmental effectiveness
• Support investigations and CAPA follow-up to ensure timely and compliant resolution of quality events
• Represent the quality function during internal audits and regulatory inspections
• Advise teams on risk management and preventive measures to enhance reliability and compliance
• Promote a culture of quality, collaboration, and process ownership across departments

Requirements

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Process Technology, or related technical field
• Minimum of 4-8 years of experience in a similar role within a GMP-regulated environment, ideally in the biopharmaceutical or process industry
• Strong understanding of validation, qualification, and GMP requirements (e.g., Annex 11, ICH, FDA, ISPE)
• Knowledge of Process Excellence tools; Lean Six Sigma Green Belt certification preferred
• Experience with risk analysis, audit preparation, and continuous improvement projects
• Excellent communication and interpersonal skills with the ability to influence cross-functional teams
• Analytical, structured, and detail-oriented mindset with a proactive attitude
• Flexible, independent, and capable of handling multiple priorities in a dynamic environment
• Fluent in English (written and spoken); additional languages are an asset

Benefits

• Region: Randstad area (Netherlands)
• Full-time on-site position in a modern GMP manufacturing environment
• Salary: between €3500 and €5500 gross monthly, based on experience and qualifications
• Contract type: temporary assignment with potential for extension
• 40-hour work week, standard day shift
• Opportunity to contribute to the development of life-saving vaccines and biotechnological innovations
• Professional development and training opportunities in process excellence and compliance
• Vacancy number: 26679