Senior Validation Specialist

Our requirements

• 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 of foundational technical platforms (platform engineering), distributed systems architectures (such as microservices) and system integration (technologies such as APIs, message brokers, stream processing). Familiarity with the platforms main technologies & programming languages: 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.
• Experience in writing validation plans and other CSV-related documentation.
• 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.

Your 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.

About the project

What we offer

• 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

• sharing the costs of sports activities
• private medical care
• sharing the costs of foreign language classes
• sharing the costs of professional training & courses
• life insurance
• remote work opportunities
• flexible working time
• dental care
• retirement pension plan
• no dress code
• video games at work
• coffee / tea
• parking space for employees
• pre-paid cards
• employee referral program
• extra leave

Digital Hub Warsaw at Bayer