CSV 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: CSV. 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 CSV (Senior) Engineer will be responsible for end-to-end validation of computerized systems & spreadsheets and quality aspects.

Responsibilities and duties

CSV & DI aspects:

  • Define validation / qualification / migration strategies per company procedures
  • Participate in the elaboration of URS
  • Participate in the selection of systems & suppliers. Provides advices and solutions to fulfil compliance
  • Define, coordinate, write and revise validation plan, protocols, reports and other documentation (FAT, SAT, IQ, OQ, PQ)
  • Attend project meetings as SME and owner of the CSV process
  • Be the key interface between users, QA, IT and suppliers for technical solutions implementation, as well as validation planning set-up
  • Coach employees and provide guidance throughout the qualification process
  • Ensure completion of validation reports, according to validation agreed timelines
  • Actively participate to problem solving and solutions proposal, with appropriate GMP documentation
  • Ensure follow-up of CSV troubleshooting operations for the entire facility
  • Ensure follow-up of compliance status for entire facility, regarding CSV rules

Quality aspects:

  • Write, revise, control and approve in a timely manner systems related QMS documentation in line with cGMP (e.g. RD, CAPA)
  • Write and update SOPs, SOPs associated documents and specifications related to CSV & DI.
  • Support the change management process from CSV & DI 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 CSV (including writing of URS/ FAT&SAT/IQ/OQ/PQ) in the Biotech or Pharma industry
  • Understanding of regulatory requirements:
    • GMP
    • EudraLex Volume 4, Annex 11 and Annex 15
    • FDA 21 CFR Part 11
    • Data Integrity 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 (oral and written) and good level of French is a plus

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