Validation Expert

Náplň práce, právomoci a zodpovednosti:

​Are you passionate about ensuring the reliability and compliance of critical IT systems in the life sciences industry? Join our Managed Services team as a Validation Expert, where you’ll play a key role in maintaining the validated state of GxP-relevant systems for long-term service engagements. This position offers the opportunity to work closely with global clients, applying regulatory best practices and driving continuous improvement in a structured service delivery model.

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Key Responsibilities

• Ensure continuous, compliant operation of GxP-relevant computer systems under Managed Services.
• Lead and coordinate validation and re-validation efforts, maintaining audit-ready lifecycle documentation.
• Support change management, upgrades, migrations, and decommissioning while preserving validation state.
• Provide ongoing compliance support aligned with 21 CFR Part 11, Part 820, EudraLex, and GAMP5.
• Collaborate with client IT, Quality, and Regulatory teams to align on validation and compliance actions.
• Standardize and reuse validation templates, protocols, and procedures across systems and clients.
• Monitor regulatory developments and adapt validation strategies accordingly.
• Integrate validation with service processes such as incident management, CAPA, and change control.
• Operate within delivery methodologies like ITIL, Agile, DevOps, and Waterfall.

Zamestnanecké výhody, benefity:

• Referral bonus depending on level of person referred
  
• Business mobile (also for private calls) and laptop
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for trainings & certifications
• Monthly events in Kosice (office)
• Free snacks & drinks in the office
• Home Office upon agreement (or possibility to work from our office in Kosice)
• Flexible working hours
• Ice Hockey ticket discounts
• Supplementary pension scheme (the third pilar) contribution
• Benefit card
• On - calls paid beyond the law
• Meal allowance beyond the law
• Company bonus (based on company financial results)

Požiadavky na zamestnanca:

• Bachelor’s degree in Computer Science, Engineering, or Life Sciences; Master’s preferred
• 5+ years of experience in computer system validation, IT compliance, or quality assurance
• Strong knowledge of FDA regulations (21 CFR Part 11, 820), GAMP5, and QMS in pharma/MedTech
• Experience with validated systems such as SAP, CTMS, Veeva Vault, MES, LIMS, and eLN
• Familiarity with ITIL-based service operations and testing automation tools
• Strong documentation, communication, and stakeholder collaboration skills
• Motivation to improve global healthcare and deliver exceptional service
• Willingness to travel up to 20% and flexibility in working hours based on project needs