Quality Engineer

Job Role: Senior Quality Engineer

About the Role:

We are seeking an enthusiastic and dedicated professional to join the Engineering-Validation-Maintenance (EVM) team at a leading pharmaceutical company in Leiden. This role focuses on ensuring GMP compliance, driving process excellence, and supporting continuous improvement across engineering, validation, and maintenance activities. You will act as a subject matter expert in quality, validation, and process optimization, collaborating with internal departments to maintain high standards in a fast-paced, regulated pharmaceutical environment.

Key Responsibilities:

• Provide leadership and expertise on quality, GMP, and validation/qualification aspects within EVM.
• Facilitate ongoing process improvement initiatives and continuous improvement programs.
• Act as subject matter expert on validation activities and GMP compliance.
• Support all EVM sub-groups in aligning internal processes and communication.
• Apply process excellence methodologies (e.g., Six Sigma, Greenbelt) to enhance efficiency and troubleshooting.
• Implement systems to visualize EVM performance, key milestones, and metrics.
• Lead processes to ensure EVM’s performance remains within GMP boundaries.
• Support handling and follow-up of CAPAs, events, and deviations.
• Conduct and follow up on internal audits.
• Serve as the Quality representative for the EVM department.
• Advise engineering and maintenance teams on process excellence and quality aspects in project execution.

Key Competencies:

• Flexible and adaptable, able to manage changing priorities and tasks.
• Strong communicator and team player, able to collaborate across departments.
• Analytical, detail-oriented, and structured with a quality-focused mindset.
• Proactive, critical thinker with a “can do” attitude.
• Committed to continuous improvement of processes, organization, and people.
• Reliable, independent, and stress-resistant.

Requirements:

• Bachelor’s degree in Mechanical, Electrical, or Process Engineering, or Installation Technics.
• 4–8 years of experience in a similar quality engineer role, or GMP-related project experience.
• Knowledge of GMP requirements, validation, and qualification of pharmaceutical or bioprocessing equipment.
• Familiarity with regulatory requirements and industry guidelines (FDA, GMP, ICH, ASTM, ISPE, etc.).
• Process excellence experience; Yellow & Greenbelt certification preferred.
• Experience in maintenance or engineering within pharmaceutical, biotechnology, or process industries is an advantage.
• English must, Dutch pre

Practicalities:

• Location: Leiden, Netherlands
• Duration: 12+ months
• Work Model: Full-time, 40 hours per week
• Start Date: ASAP

Interested or know someone who might be?

Send your CV or inquiries to [email protected] to apply or learn more.