LES / ELN Specialist @ Billennium

3 days ago

Remote, Czech Republic Billennium Full time

Pharmaceutical Industry Experience:

  • Domain knowledge in fields of biotechnology / chemistry / biochemistry / microbiology / analytical chemistry and related

Quality Control/R&D Laboratory experience:

  • Good knowledge of Ph. Eur, USP etc.
  • Familiarity with ICH, MHRA etc.
  • Experience in working in a regulated laboratory environment (ISO or GMP)
  • Experience in various laboratory techniques: Chromatography, Spectrometry, Coulometry, Particle analysis etc.
  • Experience in working with LIMS systems (LabWare, CoreLims, LabVantage)
  • Experience in working with ELN/LES systems (especially ONELab from Biovia)
  • Experience in working with:Empower, LabX, Chromeleon, Mass Hunter, OpenLab as a user and system administrator, troubleshooting resolving software issues
  • Knowledge of CSV, GAMP5, 21 CFR p. 11, EU Annex 11
  • Experience in pharmaceutical method validation and development, cleaning validation, instrument qualification
  • Good understanding of laboratory processes (certification, IPC, sample cycle etc)
  • Experience in creating documentation (GDP)

IT Related Skills/IT Related Experience:

  • Knowledge of Agile methodologies as Scrum framework (Scrum, SAFe)
  • Knowledge regarding Business Analysis (areas & techniques) BPMN fundamentals
  • Ability to work with end users to design complex workflows
  • Understanding of Data Integrity related topics
  • Preparing high quality documentation (CSV 5)
  • English B2 or higher
  • Exceptional communication skills (meeting facilitation, active listening, formal communication etiquette, transparent expression)
  • Competence to identify and address complex problems
  • Pro-activeness in searching for customer needs/problems
  • Ability to work in a team
  • Experience in working in an international environment

Nice to have:

  • Knowledge of SQL language (Oracle)
  • Experience in HP -ALM (designing test cases, executing tests, defect management)
  • Experience in ServiceNow
  • Experience in JavaScript
  • Understanding of code versioning concept


,[Creating automated laboratory workflows, Interacting with business for feedback and new recipe ideas, Reporting deffects and testing new software features, Designing new core system functionalities e.g.: reporting, interfaces.] Requirements: LIMS, ELN/LES , ISO, GAMP, Scrum, Chromatography, Spectrometry Additionally: Sport subscription, Private healthcare, International projects.