CSV / Validation Lead – GxP Computerized Systems (Basecamp 2.0)

Nasze wymagania: Minimum 3+ years of experience in IT & Software Validation (CSV, GAMP), preferably in the pharmaceutical industry Strong experience in Agile and/or Lean methodologies Hands-on experience in leading validation activities and system maintenance Proven ability to author and review validation plans, reports, and related documentation Strong understanding of SDLC within regulated environments (pharma or similar industries) Experience with regulated compliance frameworks (FDA 21 CFR Part 11, EU Annex 11) Familiarity with SAP and MES systems and their integrations Experience with Jira (backlog management) and ServiceNow (incident/change/knowledge management) Strong analytical skills with attention to detail and accuracy Excellent communication skills in English (C1 level minimum) Ability to work effectively in cross-functional and global teams Strong ownership, persistence, and ability to manage stakeholder dependencies Higher education degree in Computer Science, Software Engineering, Information Systems, or related field Mile widziane: Scrum or SAFe certification (or willingness to obtain within 6 months) O projekcie: You will join a high-performing, globally distributed team working on Basecamp 2.0, a strategic, breakthrough digital platform within Roche Technical Operations. The initiative aims to significantly reduce technology transfer cycles between Drug Development and manufacturing sites, enabling faster, more reliable, and compliant delivery of life-changing medicines. This role offers a unique opportunity to contribute to a business-critical innovation recognized by leadership as a key enabler of transformation across the pharmaceutical value chain. Zakres obowiązków: Collaborate closely with Product Owners, Scrum Masters, Architects, Developers, Business Owners, and Test Leads Define validation strategies and identify required deliverables for GxP computerized systems Review software and validation documentation in accordance with corporate CSV SOPs and regulatory requirements Estimate and plan validation activities for projects and system enhancements Author validation plans, validation reports, and review test documentation for release readiness Ensure compliance with corporate quality standards in collaboration with Quality and Informatics teams Coordinate validation activities across global teams and systems Provide expert consultancy on validation topics, testing activities, and deviation handling Lead system and functional risk assessments Support system implementation, maintenance, and validated state assurance Ensure audit readiness and support inspections as a CSV subject matter expert Lead periodic system reviews and change impact assessments Oversee data migration and production release validation activities Contribute to process optimization, governance improvements, and validation framework development Support training and knowledge sharing within the organization Provide input into system retirement and lifecycle planning