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CQV Engineer Breda SIRE Life Sciences

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Gevraagd

  • 37 - 40 uur
  • Medior/Senior
  • Engels (taal)

Aanbod

  • Vast contract
 

Vacature in het kort

Breda
Join a global biotech leader dedicated to pioneering treatments for serious illnesses. As a CQV Engineer (GMP), you will play a crucial role in technical projects, performing hands-on commissioning and qualification tasks while ensuring compliance with internal standards. You'll develop and update validation documents, lead testing activities, and provide technical support to project teams. If you're passionate about collaboration and innovation, this opportunity is for you! Read on to discover how you can shine in this role.
 

Over het bedrijf

SIRE Life Sciences
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The Company

Our client is a global biotech leader focused on developing innovative treatments for serious illnesses. With decades of groundbreaking research, they are recognized for their commitment to improving patient care through advanced medical solutions.

Role Description

As a CQV Engineer (GMP), you will support technical projects with minimal supervision, reporting to the Validation & Compliance Manager. You will perform hands-on commissioning and qualification tasks, ensuring compliance with internal standards and procedures.
 


Key Responsibilities:

Documentation:

  • Develop and update various validation documents, such as:

    • System Level Criticality Assessments

    • Validation, Commissioning, and Qualification plans

    • Risk assessments

    • Test protocols

    • Requirement traceability matrices

    • Commissioning, Qualification, and Validation summary reports

Testing:

  • Lead and participate in commissioning, qualification, and validation activities.

Technical Support:

  • Provide guidance to project teams to ensure technical solutions align with validation plans and internal requirements.

  • Ensure adherence to relevant standard operating procedures (SOPs).

Requirements

  • Bachelor’s degree in Engineering or a related field.

  • 3+ years of experience in commissioning, qualification, and validation within manufacturing or related industries.

  • Experience with computerized systems validation.

  • Hands-on experience with commissioning and qualification activities.

  • Good understanding of the validation process and documentation.
  • Familiarity with GMP compliance

Other Information
If you are passionate about working in a collaborative environment and contributing to technical projects, apply to this vacancy now!
Look forward to chatting with you!
 

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