Quality Engineer Validation

Beschreibung:

About the job

Zoetermeer/On-site
Are you ready to start your career in Quality in our Nutricia factory in Zoetermeer? In this role, you will support the Quality team and learn how to apply our high-quality and food safety standards in a dynamic production environment. You will receive guidance from experienced Quality Engineers and gain hands-on experience on the shop floor.

As a Validation Engineer, you are responsible for the execution complexity validation activities within our Nutricia factory in Zoetermeer. You ensure that equipment, processes and changes are validated in line with internal standards, food safety requirements and regulatory expectations for Medical Nutrition. Validation is the primary focus of this role. Additionally, you act as a QA Engineer back-up within the Quality team, supporting QA activities where needed. You operate independently within your scope. The factory is in continuous development, with changes in equipment, processes and layouts, making validation a key enabler for safe and compliant production.

Main Responsibilities

Validation
* Execute food safety-related (re)validation activities for oPRPs and Critical Control Points (CCPs) for existing processes that demonstrate the effectiveness of food safety control measures based on HACCP risk analyses
* Set up and maintain validation documentation, including validation plans, protocols and reports.
* Ensure validation data is complete, traceable and properly documented in the Quality Management System.
* Perform validations and revalidations related to process changes, improvements or deviations.
* Execute cleaning and CIP validation activities within established methodologies.
* Perform risk-based assessments to determine validation scope and required activities.
* Align validation outcomes with relevant stakeholders and ensure timely closure of validation actions.
Quality Engineering Activities
* Assess quality and validation impact of changes via RFC / change management processes.
* Perform and document Root Cause Analyses (RCA) related to quality, food safety or validation deviations.
* Define and follow up corrective and preventive actions (CAPA) within own area of responsibility.
* Provide input to the HACCP teams regarding the updating of HACCP documentation, procedures, and work instructions.
* Analyse quality and process data and contribute to trend analyses and improvements.
* Act as point of contact for quality-related topics within assigned processes or equipment.
* Timely close validation deliverables and align deviations with QA and Engineering stakeholders.
* Support in multidisciplinary projects regarding QA-related topics
* Back up in QA department for specific tasks

About You
* A BSc or MSc degree in Food Technology, Chemical Engineering, Mechanical Engineering or similar
* Relevant experience in validation within food, pharma or medical nutrition production.
* You like operating on the shopfloor and in multidisciplinary teams. 
* You are also able to effectively communicate with people at different levels in the organization. 
* Structured, accurate, result driven and pragmatic working style. 
* You are analytical, factual, stress resistant and able to prioritize work activities. 
* Able to assess when to act independently and when to escalate. 
* Fluent in Dutch (must-have) & English.
* Knowledge of food safety (HACCP, GMP)" descriptionHeader="
Zoetermeer/On-site
Are you ready to start your career in Quality in our Nutricia factory in Zoetermeer? In this role, you will support the Quality team and learn how to apply our high-quality and food safety standards in a dynamic production environment. You will receive guidance from experienced Quality Engineers and gain hands-on experience on the shop floor.

As a Validation Engineer, you are responsible for the execution complexity validation activities within our Nutricia factory in Zoetermeer. You ensure that equipment, processes and changes are validated in line with internal standards, food safety requirements and regulatory expectations for Medical Nutrition. Validation is the primary focus of this role. Additionally, you act as a QA Engineer back-up within the Quality team, supporting QA activities where needed. You operate independently within your scope. The factory is in continuous development, with changes in equipment, processes and layouts, making validation a key enabler for safe and compliant production.
 
Main Responsibilities
 
Validation
* Execute food safety-related (re)validation activities for oPRPs and Critical Control Points (CCPs) for existing processes that demonstrate the effectiveness of food safety control measures based on HACCP risk analyses
* Set up and maintain validation documentation, including validation plans, protocols and reports.
* Ensure validation data is complete, traceable and properly documented in the Quality Management System.
* Perform validations and revalidations related to process changes, improvements or deviations.
* Execute cleaning and CIP validation activities within established methodologies.
* Perform risk-based assessments to determine validation scope and required activities.
* Align validation outcomes with relevant stakeholders and ensure timely closure of validation actions.
Quality Engineering Activities
* Assess quality and validation impact of changes via RFC / change management processes.
* Perform and document Root Cause Analyses (RCA) related to quality, food safety or validation deviations.
* Define and follow up corrective and preventive actions (CAPA) within own area of responsibility.
* Provide input to the HACCP teams regarding the updating of HACCP documentation, procedures, and work instructions.
* Analyse quality and process data and contribute to trend analyses and improvements.
* Act as point of contact for quality-related topics within assigned processes or equipment.
* Timely close validation deliverables and align deviations with QA and Engineering stakeholders.
* Support in multidisciplinary projects regarding QA-related topics
* Back up in QA department for specific tasks" workFromHome="On-site