Senior Validation Specialist

The Data Assets, Analytics & AI team at Bayer Consumer Health focuses on digital transformation and innovation by creating analytical solutions that enable data-driven decision making and performance optimization. The role involves leading validation of the Integration Mesh system integration platform, ensuring GxP compliance, planning, execution, and documentation, and contributing to validation standards and best practices within Bayer Consumer Health.

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

• Lead the validation team and plan timelines and work for the Integration Mesh platform.
• Develop, review, and execute validation plans compliant with regulatory requirements.
• Ensure all validation documentation is accurate and aligns with standard operating procedures.
• Collaborate with cross-functional teams to identify validation requirements.
• Create Change Requests and conduct risk assessments and impact analyses for global and local systems.
• Guide the team in writing and reviewing system lifecycle documents such as requirements and technical specifications.
• Write and review protocols, reports, and other validation-related IT system documents.
• Initiate and manage approval workflows for CSV deliverables within Bayer document management systems.
• Work with global and local sites for system/module validations.
• Act as Subject Matter Expert for the Document Management System supporting queries and audits.
• Provide guidance and support to junior team members on validation best practices.
• Stay updated on industry trends, regulatory changes, and validation technology advancements including AI and digital solutions.
• Participate in audits and inspections, leading efforts related to Integration Mesh.
• Support creation and updating of training materials for systems in scope.