Qualification Engineer

Gosselies, Belgium

The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology, and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to get better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading research facility to overcome the complexicty and challenges of iPSC lineage specification. We will know we have succeeded when we can reliably and rapidly generate cell products that consistently produce positive outcomes in patients.

 

Within our Cell Therapy team in Gosselies (Belgium) there is one position immediately available: Qualification Engineer. The selected candidate will report to the Technical Services Director. We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution.

For more information about the company, please visit our website at www.cellistic.com

The position

The Qualification Engineer will be responsible for end-to-end equipment qualification activities and quality aspects.

Responsibilities and duties

Equipment qualification aspects:

  • Define qualification strategy per company procedures
  • Participate in the elaboration of URS
  • Participate in the selection of equipment & suppliers. Provides advices and solutions to fulfil compliance
  • Define, coordinate, write and revise qualification protocols/reports and other documentation (DQ, FAT/SAT, IQ, OQ, PQ)
  • Participate in collaboration with equipment owners in defining the maintenance/calibration strategy
  • Attend project meetings as equipment qualification expert
  • Coach employees and provide guidance throughout the qualification process
  • Ensure completion of qualification reports, according to qualification agreed timelines

Quality aspects:

  • Write, revise, control and approve in a timely manner Infrastructure-related QMS documentation in line with cGMP (e.g. RD, CAPA)
  • Write and update SOPs, SOPs associated documents and specifications related to infrastructure equipment.
  • Support the change management process from infrastructure perspective
  • Participate in risk assessments
  • Be involved in preparation and execution of any audits/inspection
  • Manage relationships with stakeholders

Qualifications & Experience

  • Education: Master degree in Engineering or other relevant discipline or working experience
  • Minimum 3 years working experience in equipment qualification (including writing of URS/DQ/FAT&SAT/IQ/OQ/PQ) in the Biotech or Pharma industry
  • Strong understanding of regulatory requirements
  • Experience with Quality Management Systems

Skills & Compentencies

  • Strong interaction & communication skills
  • Autonomous & proactive
  • Good organizational skills
  • Keen attention to details
  • Good writing skills
  • Can do attitude and hands-on approach
  • Strong work ethic
  • Languages: fluency in English and French (oral and written)

Job Location: Gosselies, Belgium

Position Type: Full-Time

Start Date: Immediately

We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.

Interested?

Send your motivation letter with curriculum vitae to: partnering@cellistic.com