Senior Validation Specialist

Quick Facts

• Role: Senior Validation Specialist (CSV)

Description

Lead validation activities for GxP computerized systems: define the validation approach, identify impacted deliverables, and review software documentation in line with CSV SOPs and regulatory guidance. Author validation plans and reports, review test deliverables, perform change impact assessments, and confirm data loading/migration and code release readiness. Act as a CSV subject matter expert to support audit/inspection preparation and execution.

Responsibilities

• Determine validation approach and impacted deliverables for projects, enhancements, and changes
• Review software documentation according to CSV corporate SOPs and regulatory guidance
• Provide estimates and forecasts for validation activities
• Author validation plans/reports; review test plans/reports and other deliverables to confirm readiness for go-live
• Liaise with business quality and informatics quality to ensure compliance with corporate quality policies
• Participate in validation discussions and provide consultancy on validation-related questions
• Review and collect CSV deliverables, records, and evidence according to approved plans
• Prioritize validation activities based on project schedules, business needs, and compliance requirements
• Ensure code release to production and maintenance procedures are identified and adhered to
• Confirm initial data loading and/or data migration is performed according to approved procedures
• Assess changes to determine potential impact to the validated state
• Support system maintenance with validated state and permanent audit readiness
• Observe governance processes and escalate improvement opportunities
• Support system audit/inspection preparation and execution as CSV SME
• Implement relevant frameworks and processes; propose and use tools
• Provide training and validation/quality knowledge exchange support

Requirements

• 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma
• Mandatory experience with Lean and/or Agile approaches
• Experience leading validation for projects and systems/applications maintenance
• Experience authoring validation plans, reports, and deliverable registries
• Experience authoring or reviewing validation deliverables, records, and other evidence
• Experience with SDLC processes and pharmaceutical (or other regulated) models/standards
• Experience supporting applications under global inspection agencies, including CFR 21 FDA Part 11 and Annex 11
• Awareness of common development technologies and governance processes impacting validation
• Ability to work collaboratively in cross-functional teams to achieve milestones
• Strong written and verbal communication skills (English C1)
• Ability to share knowledge and guide others; ability to make sound quality and technical decisions
• Follow-through and persistence with globally spread stakeholders
• Hands-on experience with Retina or JIRA (backlog management)
• Hands-on experience with ServiceNow (Incident, Change, Knowledge Management)
• Higher education degree or relevant work experience in computer science/software engineering/information systems and/or pharma

Benefits

• Participation in interesting and demanding projects
• Flexible working hours
• Stable employment conditions (contract of employment or B2B)
• Opportunities for development and promotion
• Attractive benefits package
• Remote or hybrid work model (2 days per week from the office)
• Non-corporate atmosphere