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CQV Engineer

In partnership with a global bio-pharmaceutical company in Breda, we are searching a CQV Engineer.
This role requires hands-on commissioning and qualification skills, ensuring that technical solutions align with internal customer requirements and CQV procedures.

RESPONSIBILITIES

Develop and update various Validation documents, including:
System-Level Criticality Assessments
Validation, Commissioning, and Qualification Plans
Risk Assessments
Test Protocols
Requirement Traceability Matrices
Commissioning, Qualification, and Validation Summary Reports
Perform Commissioning, Qualification, and Validation (CQV) activities to ensure compliance with standards and regulations.
Provide guidance to the project team, ensuring that technical solutions align with the validation plan, meet internal customer requirements, and comply with Amgen SOPs.

Assist in troubleshooting and resolving technical issues during project execution.
Perform any other tasks or projects as assigned by the supervisor.
PROFILE
Experience with Secondary Packaging Systems, including Print and Inspection systems (e.g., Systech, Cognex).
Minimum of 3 years’ experience in CQV within pharmaceutical manufacturing.
Experience in CSV.
Hands-on experience with commissioning and qualification in Secondary Packaging Operations.
Ability to anticipate, evaluate, and resolve multiple project issues, delays, and technical challenges by leveraging business and technical expertise.

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