Senior Validation Lead - CSV & GxP for Integration Mesh

Biopharma Careers; Warszawa; On-site; PLN 206,000 - 246,000; Full time

Benefits offered by this job

Medical care

Flexible benefits

Insurance: life, accident, disability

Pension plans

Home office allowance

Extra paid holidays

Job summary

Bayer is seeking a Senior Validation Specialist for its Digital Hub Warsaw. You will lead validation of the Integration Mesh platform and ensure GxP compliance across global and local components, driving standards and collaboration with the quality team.

You will develop validation plans, write protocols, and manage audits while coordinating cross-functional teams. English fluency and travel readiness are essential for this fast-paced, high-impact role.

Qualifications

• Bachelor’s degree in Computer Science, Technology, or a related field.
• Minimum of 7+ years of experience in validation of computer systems within the pharmaceutical or medical device industries with prior experience in leading validation projects.
• Good understanding of GxP requirements, experience in writing validation plans and other CSV-related documentation.
• Strong IT background with experience working with or validating foundational technical platforms (platform engineering), distributed systems architectures (microservices) and system integration (APIs, message brokers, stream processing).
• Proven ability to communicate effectively, both verbally and in writing and ability to guide junior team members.
• Strong analytical and problem-solving skills with attention to CSV documents.
• Ability to work independently and as part of a team in a fast-paced environment.
• Fluent in English and ability to travel occasionally.

Responsibilities

• Lead the validation work and the validation team for the whole Integration Mesh platform, plan timelines, and align with the quality team.
• Develop, review, and execute validation plans for computer systems in compliance with regulatory requirements.
• Ensure all validation documentation is accurate, complete, and in accordance with SOPs 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 for global and local systems/modules.
• Guide the team in writing system lifecycle documents such as requirements and technical specifications for CSV.
• Write and review protocols, reports, and related documents for IT systems in the context of validation.
• Manage approval workflows for CSV deliverables in Bayer document management systems.
• Coordinate with global and local sites on global/local systems/modules.
• Act as SME for the Document Management System to support queries and audits.
• Provide guidance to junior team members on validation practices and methodologies.
• Stay updated on regulatory changes and advancements in validation technologies, including AI.
• Participate in audits and inspections, provide documentation and insights as required.
• Support trainingMaterial creation for scope systems.

Skills

GxP validation

Team leadership

Regulatory compliance

Cloud/AWS

API integration

Microservices

Technical writing

QA documentation

Audit readiness

Stakeholder communication

Education

Bachelor’s degree in Computer Science or related field

Tools

AWS SQS

AWS Lambda

Terraform

Node.js

GitHub

Job description

Bayer is seeking a Senior Validation Specialist for its Digital Hub Warsaw. You will lead validation of the Integration Mesh platform and ensure GxP compliance across global and local components, driving standards and collaboration with the quality team.

You will develop validation plans, write protocols, and manage audits while coordinating cross-functional teams. English fluency and travel readiness are essential for this fast-paced, high-impact role.