Process Engineering Associate Leiden • SIRE Life Sciences

The Company
Our client is a frontrunner in the biopharmaceutical manufacturing sector, specializing in innovative medicines and MedTech solutions. Their expertise drives the development of pioneering healthcare solutions that prevent, treat, and cure complex diseases. Committed to excellence, safety, and compliance, our client is currently expanding their operations in the Netherlands to further support global healthcare initiatives.

The Role
As a Process Engineering Associate, you will play a key role in supporting the implementation, validation, qualification, and maintenance of automated manufacturing systems at the Leiden facility. You will work closely with project teams to ensure that systems comply with regulatory standards, such as cGMP, and align with manufacturing best practices. In addition, you'll collaborate with IT and project engineers to manage system modifications and optimize data pipelines, enhancing the efficiency and reliability of manufacturing operations.

Responsibilities
-Assist with the implementation, validation, and qualification of automated manufacturing systems.
-Support the maintenance and troubleshooting of automated systems to ensure their continuous performance.
-Ensure compliance with cGMP and other regulatory requirements throughout the entire system lifecycle.
-Collaborate with IT and project engineers to manage system changes and improvements.
-Contribute to the enhancement of data pipelines, ensuring seamless data flow for manufacturing processes.
-Provide technical support to ensure smooth operations of the systems.

Requirements
-A bachelor's degree or higher in Industrial Automation, Process Engineering, or a related engineering field.
-Familiarity with industry standards such as cGMP, GxP, and other applicable regulatory guidelines.
-Proficiency in English (additional language skills are a plus).
-Experience with data management and integration, including working with data pipelines.
-Hands-on experience with the implementation, validation, and maintenance of automated manufacturing systems, ideally within a regulated environment.

Other Information
Are you interested and would you like to apply for this position? Please submit your application using the application button below and contact Zahra Souhali.

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