Process Engineer, Leiden, Zuid-Holland

The Company
A leading global organization in the pharmaceutical industry dedicated to improving health and well-being. They focus on innovation, quality, and operational excellence, ensuring their production processes meet the highest standards and regulatory requirements.

Role Description
We are seeking a dedicated Process Engineer to support and optimize manufacturing processes within our client’s pharmaceutical operations. The role involves maintaining existing processes, leading improvement initiatives, and ensuring compliance with regulatory standards to facilitate continuous process enhancement.

Responsibilities
- Maintain and improve production processes, ensuring they operate within validated and regulatory limits.
- Collaborate with management and operational teams to develop and implement process engineering methods aimed at increasing efficiency and quality.
- Lead process improvement projects, including data collection, analysis, and reporting to identify opportunities for optimization.
- Supervise and assess process performance to ensure targets such as yield and output are achieved.
- Support the introduction of new production processes and systems, facilitating seamless technical transfer and NPI activities.
- Conduct process assessments, including Gemba walks, to observe operations and lead sustainable safety, quality, and reliability improvements.
- Lead risk assessments related to safety, product quality, and regulatory compliance, supporting issue resolution processes.
- Prepare and manage documentation for process change controls, Impact Assessments, and related activities.
- Collaborate cross-functionally to implement strategies that reduce downtime and process losses, driving continuous improvement.
- Engage in ongoing process verification activities and conduct additional research as needed to support process stability.

Requirements
- A relevant university degree or equivalent professional experience with at least 3 years of demonstrated success in pharma or process engineering.
- Proficiency in Dutch (A2 level) and English (C1 level).
- Intermediate skills in MS Office, with routine data analysis abilities and experience with business applications.
- Strong analytical mindset, capable of handling complex issues, asking insightful questions, and developing creative solutions.
- Proactive, organized, and capable of working independently or as part of a team.

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

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