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Engineer Elektrotechniek

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Process Validation Engineer Breda • SIRE Life Sciences
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Gevraagd
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37 - 40 uur
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Medior/Senior
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Engels (taal)
Aanbod
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Vast contract
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The Company
Our client is an innovative organization at the forefront of scientific and technological advancement. Committed to improving lives, the company leverages cutting-edge research to develop therapies for serious diseases, continuously growing its pipeline to meet urgent medical needs.
Role Description
As a Process Validation Engineer, you’ll play a key role in executing technical projects with minimal supervision, reporting directly to the Sr. Manager of Validation & Compliance within the Engineering team. This hands-on role focuses on commissioning, qualification, and validation (CQV) activities, ensuring technical solutions meet internal standards, customer requirements, and regulatory expectations.
Responsibilities
-Develop and maintain comprehensive CQV documentation, including System Level Criticality Assessments, Commissioning, Qualification, and Validation (CQV) Plans, Risk Assessments, Test Protocols, Requirements Traceability Matrices and Summary Reports
-Lead and execute commissioning, qualification, and validation testing across systems, ensuring all activities are aligned with SOPs and validation strategies.
-Provide technical guidance to project teams to ensure validation activities meet compliance standards and internal customer needs.
-Collaborate across departments to ensure integration and alignment of CQV efforts with broader engineering and operational goals.
-Carry out additional tasks or support other projects as assigned by the supervisor.
Requirements
-Minimum of 3 years' experience in CQV within pharmaceutical manufacturing environments.
-Practical experience with secondary packaging systems and inspection technologies (e.g., Systech, Cognex).
-Strong background in Computerized Systems Validation.
-Hands-on experience with commissioning and qualification in Secondary Packaging Operations.
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.
55112
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