Senior CSV / CSA Validation Engineer

Описание

We are looking for an experienced CSV / CSA Validation Engineer to ensure that IT systems are validated, compliant, and reliable within a regulated environment. This role focuses on assessing, validating, and documenting computer systems in accordance with GxP requirements, while supporting system implementations, upgrades, and changes. 

You will work closely with business stakeholders, QA, and cross-functional Agile teams to ensure systems meet regulatory standards and business needs. The ideal candidate has a strong understanding of risk-based validation (CSA), regulatory frameworks, and the full system validation lifecycle. 

Experience / Skills required: 

Must have: 

4+ years of hands-on experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industries (pharma, biotech, medical devices, life sciences)   Strong practical knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP computer system requirements  Proven experience participating in validation of 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, collaborating 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 lifecycle  Excellent communication skills in English (written and spoken) for cross-functional collaboration and documentation  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 new validated systems, validated system upgrades, or validated system modifications effectively and efficiently  Assist as an Agile Team Member on CSV projects under a CSA and GAMP lifecycle framework.  Able to author, execute, review, and/or approve system lifecycle documents (System and Change Assessments, Validation Plans, Specifications, Risk Assessments, Qualifications, Traceability, Standard Operating Procedures, Summary Reports)  Maintain a close relationship with all Agile Team members and QA Compliance to ensure appropriate validation of GxP computer systems 

We offer:  

Competitive salary with the regular review  Medical Insurance after 3 months probation period (can be used in Ukraine)  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, remote, office-based or hybrid format Fully-equipped perfect office space located in the city center (ready for work in blackouts)  Direct cooperation with the customer  Dynamic environment with low level of bureaucracy and great team spirit  Challenging projects in diverse business domains and a variety of tech stacks  Communication with Top/Senior level specialists to strengthen your hard skills  Online/offline teambuildings  Volunteering culture development and support