Senior Validation Lead — CSV for Digital Platform (Hybrid)

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

Benefits offered by this job

Medical care above statutory

Flexible benefits

Life, accident, and disability保险

Employer-supported pension plans

Home office allowance

Job summary

Bayer Digital Hub Warsaw is seeking a Senior Validation Specialist to lead validation efforts for the Integration Mesh platform. You will drive GxP compliant validation Programs, plan timelines, and collaborate with quality and cross‑functional teams to ensure robust documentation and compliant operations.

You will mentor junior team members, write validation documents, and stay current with regulatory changes and AI‑assisted tooling, contributing to a dynamic digital transformation in Bayer

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). Familiarity with AWS SQS, AWS Lambda, Terraform, Node.js, GitHub. 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.
• Strong analytical and problem-solving skills attention to details when it comes 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 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 organizations standard operating procedures and policies.
• Collaborate with cross-functional teams to identify validation requirements and ensure successful implementation.
• Create the Change requests and conduct risk assessments and impact analyses to determine the validation approach for various systems that are Global and local.
• Guide the team in writing and reviewing system lifecycle documents such as requirements, technical specifications and other general documents related to CSV.
• Write and review protocols, reports, and other related documents for IT systems in the context of validation.
• Initiate and handle approval workflows for CSV deliverables in Bayer document management systems.
• Work with global and local sites in cases where the system or module is a global or local system/module.
• Act as a Subject Matter Expert (SME) for the Document Management System (DMS) to support queries from cross-functional teams or during audits.
• Provide guidance and support to junior team members regarding validation best practices and methodologies.
• Stay updated on industry trends, regulatory changes, and advancements in validation technologies, including AI and digital solutions.
• Participate in audits and inspections, lead them from Integration Mesh perspective, providing necessary documentation and insights as required.
• Support in creating and updating training materials for systems in scope to support business.

Skills

Fluent English

Communication

Mentoring/Lead

Education

Bachelor's degree in CS/Technology

Tools

AWS SQS

AWS Lambda

Terraform

Node.js

GitHub

Job description

Bayer Digital Hub Warsaw is seeking a Senior Validation Specialist to lead validation efforts for the Integration Mesh platform. You will drive GxP compliant validation Programs, plan timelines, and collaborate with quality and cross‑functional teams to ensure robust documentation and compliant operations.

You will mentor junior team members, write validation documents, and stay current with regulatory changes and AI‑assisted tooling, contributing to a dynamic digital transformation in Bayer