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Senior Quality Engineer Leiden Panda International

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Gevraagd

  • Fulltime
  • Expert

Aanbod

  • Loondienst (tijdelijk)
 

Vacature in het kort

Leiden
Join the Engineering-Validation-Maintenance (EVM) team as a Senior Quality Engineer at a top pharmaceutical company. Drive GMP compliance and process excellence while championing continuous improvement in a dynamic, regulated setting. Act as a quality expert in validation and process optimization, collaborating across departments. Enjoy excellent continuous improvement initiatives, utilizing methodologies like Six Sigma. With flexible responsibilities, your expertise will shape high standards in an innovative environment. Keep reading for more information on this exciting opportunity.
 

Over het bedrijf

Panda International
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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 via de button "Solliciteer nu" op deze pagina. to apply or learn more.

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