Senior Validation Lead - CSV & GxP (Remote/Hybrid)

Bayer; Warszawa; Hybrid; PLN 206,000 - 246,000; Full time

Benefits offered by this job

Medical care above statutory

Flexible benefits

Life insurance

Pension plans

Home office allowance

Extra paid holidays

Job summary

Bayer Warsaw is seeking a Senior Validation Specialist to lead validation of the Integration Mesh platform, ensuring GxP compliant operations and documentation. You will guide the team, develop validation plans, and align with quality and cross-functional stakeholders.

The role focuses on system validation, lifecycle documentation, audits, and adopting best practices in a dynamic data analytics environment within Bayer Consumer Health.

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.
• Strong IT background with experience working with or validating foundational technical platforms and system integration.
• Familiarity with AI and AI-augmented tooling is a plus.
• Proven ability to communicate effectively, both verbally and in writing and ability to guide junior team members.

Responsibilities

• Lead the validation work and the validation team for the whole integration Mesh platform, plan timelines, and work of the team, and align with the quality team.
• Develop, review, and execute validation plans for computer systems in compliance with regulatory requirements.
• Ensure that 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 to determine validation approaches for global and local systems.

Skills

Leadership

GxP knowledge

Communication skills

Validation planning

Problem solving

Education

Bachelor’s degree in Computer Science or related field

Tools

AWS SQS

AWS Lambda

Terraform

Node.js

GitHub

Job description

Bayer Warsaw is seeking a Senior Validation Specialist to lead validation of the Integration Mesh platform, ensuring GxP compliant operations and documentation. You will guide the team, develop validation plans, and align with quality and cross-functional stakeholders.

The role focuses on system validation, lifecycle documentation, audits, and adopting best practices in a dynamic data analytics environment within Bayer Consumer Health.