GMP Process Equipment Engineer, Leiden, Zuid-Holland

Location: Leiden, Zuid-Holland  |  Sector: Biotechnology  |  Start Date: 11/12/2026  |  Job ref: 59528

The Company
Our client is a leading organization within the biopharmaceutical industry, focused on developing and manufacturing innovative medicines. The organization operates in a highly regulated GMP environment, with a strong commitment to product quality, patient safety and operational excellence.

About the Role
We are looking for an experienced GMP Process Equipment Engineer to join the Centre of Expertise within Primary Recovery (PR). In this role, you will support, maintain and improve critical manufacturing equipment and systems, focusing on equipment reliability, contamination prevention and continuous improvement within a GMP-regulated biopharmaceutical manufacturing environment.

Responsibilities
- Ensure GMP compliance through regular reviews of equipment documentation, processes and procedures.
- Lead an Asset Team to maintain accurate asset data, identify equipment issues and support asset replacement planning.
- Support the introduction and implementation of new process equipment and systems.
- Investigate equipment failures and inefficiencies through root cause analysis in collaboration with Troubleshooters and Operations teams.
- Develop and implement improvement strategies to reduce equipment downtime and operational losses.
- Conduct Gemba walks to assess equipment usage and identify improvements in safety, quality, reliability, cost and scheduling.
- Act as a subject matter expert in contamination prevention, promoting best practices across multidisciplinary teams.
- Develop training programmes and encourage a culture of continuous improvement, collaboration and knowledge sharing.


Requirements
- Bachelor's or Master's degree in Bioprocessing, Chemical Engineering, Microbiology or a related technical field.
- Minimum 3 years of experience in biopharmaceutical processing with a Bachelor's degree, or 1.5 years with a Master's degree.
- Knowledge of GMP requirements and upstream processing operations.
- Professional English proficiency (B2 level).
- Strong analytical and root cause investigation skills.
- Experience with manufacturing equipment, process improvements and equipment reliability.
- Ability to work independently and collaborate effectively within multidisciplinary teams.
- Strong communication skills and the ability to identify and escalate operational risks.


Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.

59528

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Mahesh Kalyani

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