Validation Lead

We are seeking a skilled and experienced Validation lead to join our team. The ideal candidate will have at least 7 years of experience in the validation of computer systems within the pharmaceutical or medical device industries, along with a solid IT background. This role requires effective communication skills, the ability to write comprehensive validation plans and other required deliverables for CSV, and a strong understanding of Computer System Validation (CSV) processes. Knowledge of Veeva systems validation is a key qualification for this role, additionally, digital technologies, including AI, is a plus.

Key tasks and responsibilities:

• 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.

• Support 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 is a global or local system.

• 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, providing necessary documentation and insights as required.

• Support in creating and updating training materials for systems in scope to support business.

Qualifications & competencies:

• Bachelor’s degree in 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 knowledge of Veeva software and systems.

• Proven ability to communicate effectively, both verbally and in writing.

• Experience in writing validation plans and other CSV-related documentation.

• Familiarity with digital technologies and AI is a plus.

• 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.

What do We offer:

• A flexible, hybrid work model

• Great workplace in a new modern office in Warsaw

• Career development, 360° Feedback & Mentoring programme

• Wide access to professional development tools, trainings, & conferences

• Company Bonus & Reward Structure

• VIP Medical Care Package (including Dental & Mental health)

• Holiday allowance (“Wczasy pod gruszą”)

• Life & Travel Insurance

• Pension plan

• Co-financed sport card - FitProfit

• Meals Subsidy in Office

• Additional days off

• Budget for Home Office Setup & Maintenance

• Access to Company Game Room equipped with table tennis, soccer table, Sony PlayStation 5 and Xbox Series X consoles setup with premium game passes, and massage chairs

• Tailored-made support in relocation to Warsaw when needed

• Please send your CV in English

You feel you do not meet all criteria we are looking for? That doesn’t mean you aren’t the right fit for the role. Apply with confidence, we value potential over perfection

WORK LOCATION: WARSAW AL.JEROZOLIMSKIE 158