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Описание: |
We are looking for an experienced Senior CSV / CSA Validation Engineer to ensure that IT systems are validated, compliant, and reliable within a regulated environment. The role focuses on assessing, validating, and documenting computer systems in accordance with GxP requirements while supporting system implementations, upgrades, and changes.
Project — involves working with regulated IT systems within life sciences and related industries, ensuring compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The engineer will collaborate closely with business, QA, and Agile teams to deliver validated systems that meet both regulatory standards and business needs.
Must have:
* 4+ years of hands-on experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industries.
* Strong practical knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP computer system requirements.
* Proven experience validating new systems, system upgrades, and system changes.
* Ability to author, execute, review, and approve system lifecycle documentation.
* Experience working in Agile or hybrid Agile environments with Product Owners, Business Owners, SMEs, QA, and IT teams.
* Strong understanding of risk-based validation approaches (CSA mindset).
* Experience supporting GxP-compliant systems throughout their full lifecycle.
* Excellent English communication skills (written and spoken).
* Strong attention to detail, organizational skills, and ability to manage multiple validation activities in parallel.
Responsibilities:
* Work closely with Agile Project Stakeholders (Site Leaders, Business Owners, Product Owners, SMEs, and QA) to implement validated systems, upgrades, and modifications.
* Act as an Agile Team Member on CSV projects under CSA and GAMP lifecycle frameworks.
* Author, execute, review, and approve lifecycle documentation including Validation Plans, Risk Assessments, Specifications, Qualifications, Traceability, SOPs, and Summary Reports.
* Maintain close collaboration with Agile teams and QA Compliance to ensure appropriate validation of GxP computer systems.
We offer:
* Competitive salary with regular performance reviews.
* Medical insurance after 3 months probation period.
* Vacation up to 20 working days.
* Paid sick leaves (10 working days).
* National holidays as paid time off (11 days).
* Online English courses.
* Accountant assistance and legal support.
* Flexible working schedule with remote, office-based, or hybrid options.
* Fully equipped office in the city center with readiness for blackouts.
* Direct cooperation with the customer.
* Dynamic environment with low bureaucracy and strong team spirit.
* Challenging projects across diverse business domains and technology stacks.
* Collaboration with Top/Senior-level specialists to strengthen technical skills.
* Online and offline team buildings.
* Support for volunteering initiatives and social impact activities.
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