Senior Validation Specialist

The minimum monthly gross compensation for this role is 20 240 PLN gross. Final pay is determined based on objective factors such as experience, qualifications, scope of responsibility, and internal alignment.

This position is eligible for variable pay components, such as performance-based bonuses, in accordance with the applicable employee group, role scope, and compensation structure.

Benefits

• Medical care above statutory requirements
• Flexible benefits supporting leisure and well-being/sports programs
• Life, accident, and disability insurance through group coverage
• Employer-supported pension plans with regular company contributions
• Home office allowance to support hybrid or remote work
• Extra paid holidays

Benefits may vary depending on country, role, and employment conditions.

Description

The Data Assets, Analytics & AI team focuses on digital transformation and innovation by creating analytical solutions that enable data-driven decision-making and performance optimization.

You will lead validation for the Integration Mesh system integration platform. You will lead the GxP validation process for new platform components and enhancements, ensure GxP-compliant operations, and contribute to validation standards and best practices. Responsibilities include planning, execution, and documentation.

Key Responsibilities

• Lead validation work and the validation team for the Integration Mesh platform; plan team timelines and work, and align with the quality team
• Develop, review, and execute validation plans for computer systems in compliance with regulatory requirements
• Ensure validation documentation is accurate, complete, and aligned with standard operating procedures and policies
• Collaborate with cross-functional teams to identify validation requirements and ensure successful implementation
• Create change requests and conduct risk assessments and impact analyses to determine validation approaches for global and local systems
• Guide the team in writing and reviewing system-lifecycle documents, including requirements and technical specifications
• Write and review validation protocols, reports, and related IT-system documentation
• Initiate and manage approval workflows for CSV deliverables in document management systems
• Work with global and local sites for global or local systems and modules
• Act as a subject-matter expert for the Document Management System, supporting cross-functional queries and audits
• Provide validation best-practice guidance and support to junior team members
• Stay current on industry trends, regulatory changes, and validation technologies, including AI and digital solutions
• Participate in and lead audits and inspections from the Integration Mesh perspective, providing required documentation and insights
• Create and update training materials for systems in scope to support the business

Qualifications

• Bachelor’s degree in Computer Science, Technology, or a related field
• At least 7 years of experience validating computer systems in pharmaceutical or medical-device industries, including experience leading validation projects
• Strong IT background and experience working with or validating foundational technical platforms, distributed-system architectures such as microservices, and system integration technologies including APIs, message brokers, and stream processing
• Familiarity with AWS SQS, AWS Lambda, Terraform, Node.js, and GitHub
• Familiarity with AI and AI-augmented tooling is a plus
• Effective verbal and written communication skills, including the ability to guide junior team members
• Experience writing validation plans and other CSV-related documentation
• Strong analytical and problem-solving skills, with attention to detail in CSV documentation
• Ability to work independently and as part of a team in a fast-paced environment