At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. 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’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
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 modelGreat workplace in a new modern office in WarsawCareer development, 360° Feedback & Mentoring programmeWide access to professional development tools, trainings, & conferencesCompany Bonus & Reward StructureVIP Medical Care Package (including Dental & Mental health)Holiday allowance (“Wczasy pod gruszą”)Life & Travel InsurancePension planCo-financed sport card - FitProfitMeals Subsidy in OfficeAdditional days offBudget for Home Office Setup & MaintenanceAccess 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 chairsTailored-made support in relocation to Warsaw when neededPlease 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
YOUR APPLICATIONBayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Bayer offers the possibility of working in a hybrid model. We know how important work-life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager.
Bayer respects and applies the Whistleblower Act in Poland.
Location:
Poland : Mazowieckie : Warszawa
Division:
CH
Reference Code:
850380