CQ Engineer (CQV) x 2 Ref:1616


SPGL is a dynamic and well established professional technical services group, operating in a range of market sectors including Bio-Pharmaceuticals, Medical Devices & Diagnostics, Healthcare, Regulated Consumer Products, Chemicals & Mission Critical. We are a responsible, diverse and inclusive organisation, driven by our vision of ‘making quality a way of life’ and a strong desire to achieve more for our customers. We are proud to have a great team of highly skilled, smart professionals who help, care and support both our clients and each other.


  • 1x CQV Engineer – Production / Process equipment inside the clean room
  • 1x CQV Engineer – Clean (& Black) Utilities
  • Working in a department of 25 engineers
  • GMP background
  • Quality & Compliance mindset
  • University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
  • Expert in the field of quality/validation activities & control tests, cGMP and EMA/FDA
  • Understanding of good practices in biopharmaceuticals, current Industry standards, regulatory requirements and Authority expectations regarding CQV.
  • Experience in Pharmaceutical production environment, commissioning & qualification.
  • You have a good Comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
  • Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
  • Use a risk-based approach for problem solving and prioritization of tasks.
  • Good GMP background and quality system management
  • Blow a quality and compliance mindset through the qualification activities.
  • You have a field experience with:
  • CQV activities for upstream equipment
  • Change management
  • Project document management
  • Strong communication, organizational and influencing skills to work transversely.
  • Good team player, who can also work independently.
  • You speak and write fluent English, Dutch and/or French


  • To ensure oversight of the commissioning (FAT, SAT) & qualification (IQ, OQ, PQ) activities
  • Responsible for reviewing and approving commissioning and qualification documents (Risk Assessment, SAT, qualification protocols and reports, …)
  • Coordinate and facilitate punch list items / incidents resolution
  • Ensure CQV protocols are executed according to Good Documentation Practices
  • Support during system/installation start-up in function of CQV test activities
  • Coordinate the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation)
  • Coordinate the implementation of adequate qualification strategy in compliance with FDA, EMEA and International quality standards
  • Provide support for inspection readiness – regarding system Validation
  • Coordinate the review process of CQV deliverables with stakeholders
  • Escalate quality issues after CQV testing and maintain project KPI related to CQV activities
  • Play the link between PE department and QA stakeholder to address blocking points
  • Coordinate change controls for GMP and GEP systems
  • Support risk analysis activity as required per the project
  • Accountable for writing Validation report
  • Coordinate the handover process with the users
  • Build a strong partnership with key stakeholders; both internal & external

What SPGL can offer you

We are a people centric company where our staff are the heart and soul of our organisation. If you’re looking for a forward-thinking workplace and see yourself as a dynamic professional, come and join our team and you can expect:

  • Competitive starting salary
  • Excellent private healthcare
  • Pension and life insurance
  • A variety of challenging projects, with blue-chip customers
  • International project assignments
  • Continuous training and personal development
  • Strong career pathway
  • A mix of young and experienced professionals
  • Multi-cultural and caring organisation
  • An equal opportunity employer
  • Regular team building events and social gatherings

For further information on this role please e-mail careers@spgl.eu