CQV Engineer

Location Kingdom of Belgium
Discipline: Biotechnology
Job type: Freelance
Contact name: Caitlin Girdwood

Contact email: c.girdwood@panda-int.com
Job ref: 12328
Published: 17 days ago

My client is a renowned Biotech in Belgium who are currently searching for several Engineers (CQV; Process; Utilities) to support on-going projects and expansion to existing plants. They are a fast-paced, innovative company, and look for dynamic people who can enjoy the ride with them! Right now, they urgently need a CQ Engineer to support the teams in achieving their project goals.

Job purpose:

Hands-on attitude, motivated, quality mindset and responsible in, coordinating, and reviewing CQV deliverables in line with project specifications in cooperation with  project team

Responsibilities:

  • 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 punchlist 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

 

Profile:

  • 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
  • You speak and write fluent English, Dutch and/or French

Contract Details

  • Start date: November 2021.
  • Contract duration: Till end of Q2 2022 with option for extension.
  • Project/Mission duration: Till end of Q2 2022.
  • Type of project(s): Utilities & Production capacity extension & improvement projects.