Senior Validation Specialist

Bayer CropScience Limited; Warszawa; On-site; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Flexible benefits

Life insurance

Pension plan

Home office allowance

Extra holidays

Job summary

Bayer CropScience Limited in Warsaw is seeking a Sr. Validation Specialist to lead validation activities for computer systems in pharma/medical devices.

You will develop validation plans, oversee documentation, and guide a team across aisles of IT and quality assurance, ensuring compliance with CSV standards and regulatory requirements. The role requires 7+ years of validation experience, strong technical background in distributed systems, and experience with platform engineering.

Qualifications

• 7+ years of validation experience in pharma or medical devices.
• Experience leading validation projects and teams.
• Strong documentation skills for CSV compliance.

Responsibilities

• Lead validation work for the Integration Mesh platform.
• Develop and execute validation plans per regulatory requirements.
• Collaborate with global sites and QA teams.

Skills

Leadership

Communication

Analytical skills

CSV documentation

Regulatory awareness

Problem solving

Team mentorship

Cross-functional

Education

Bachelor's degree in CS

Tools

AWS SQS

AWS Lambda

Terraform

Node.js

GitHub

Job description

Benefits

• 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 may vary depending on country, role, and employment conditions.

Sr. Validation Specialist

We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible'. 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. 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. 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.