Quality Engineer

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.

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.

Practicalities

Duration: 12+ months

Work Model:
Full-time, 40 hours per week

Start Date:

ASAP

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