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Solution Architect

2 weeks ago

Remote, Czech Republic Billennium Full time

Pharmaceutical Industry Experience:

  • Hands-on experience working in a regulated environment (ISO or GMP)
  • Knowledge of CSV, GAMP5, 21 CFR Part 11, EU Annex 11 (minimum basic CSV knowledge required; previous experience in validated projects is a strong plus)
  • Experience in creating documentation in compliance with GxP requirements

IT / Architecture Skills:

  • Knowledge of Agile methodologies (Scrum, SAFe)
  • Understanding of business analysis areas & techniques, BPMN fundamentals
  • Ability to work with end users to design complex workflows
  • Knowledge of SQL (Oracle)
  • Experience with HP-ALM (test case design, test execution, defect management
  • Experience with ServiceNow
  • Strong command of English (C1 or higher)
  • Exceptional communication skills, problem-solving abilities, and proactiveness
  • Experience working in an international environment

Nice to Have:

Laboratory Experience:

  • Knowledge of Ph. Eur, USP
  • Familiarity with ICH, MHR
  • Experience in laboratory techniques: Chromatography, Spectrometry, Coulometry, Particle Analysis, etc.
  • Experience with LIMS systems (LabWare, CoreLims, LabVantage)
  • Experience with ELN/LES systems (especially ONELab from Biovia)
  • Experience with Empower, LabX, Chromeleon, Mass Hunter, OpenLab (as user/admin, troubleshooting)
  • Good understanding of lab processes (certification, IPC, sample cycle).
  • Experience in documentation creation (GDP)

Additional IT Skills:

  • JavaScript knowledge
  • Understanding of code versioning concepts
  • Understanding of data integrity principles
  • Experience preparing high-quality documentation (CSV 5)
,[Design and develop new core system functionalities (e.g., reporting, interfaces), Collaborate with business teams, analysts, and developers to define and implement solutions, Ensure compliance with GxP and relevant industry regulations, Create and maintain project documentation in line with CSV requirements, Support system validation processes (Computer System Validation)] Requirements: BPMN, SQL, HPALM, ServiceNow, GXP, CSV, LIMS, ELN/LES Additionally: Sport subscription, Training budget, Private healthcare, International projects.