CQV Engineer, Breda, Noord-Brabant

The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.

Role Description
The CQV Engineer will support packaging-related commissioning, qualification, and validation activities within a GMP-regulated environment. The role involves hands-on execution of CQV tasks, development of validation documentation, and support of secondary packaging systems, including print and inspection technologies such as Systech and Cognex.

Responsibilities

• Develop, update, and review validation documents, including system criticality assessments, validation and qualification plans, risk assessments, test protocols, and commitment traceability matrices.
• Lead and execute commissioning, qualification, and validation activities for secondary packaging systems, including print and inspection equipment.
• Provide technical guidance to project teams, ensuring activities adhere to validation plans and GMP standards.
• Support the creation of detailed reports summarizing commissioning, qualification, and validation outcomes.
• Collaborate with internal teams to develop and implement test strategies aligned with customer requirements and internal SOPs.

• Minimum of 2 years’ experience in commissioning, qualification, and validation within pharmaceutical manufacturing.
• Hands-on experience with secondary packaging systems, including print and inspection technologies (e.g., Systech, Cognex).
• Strong understanding of Computerized Systems Validation.
• Proven ability to develop and manage validation documentation.
• Good technical writing and communication skills in English.

56927