Senior Validation Specialist

Senior Validation Specialist

Miejsce pracy: Warszawa

Technologies we use

Operating system

• Windows

About the project

The Data Assets, Analytics & AI team at Bayer Consumer Health focuses on bringing digital transformation and innovation by creating best in class analytical solutions enabling data-driven decision making and performance optimization for Bayer Consumer Health organization.

You will be part of the Data Assets, Analytics & AI organization and are responsible to lead the validation of our system integration platform called Integration Mesh. In that role, you will be responsible to lead the GxP validation process new platform components and enhancements. In additional you will ensure a GxP compliant operation. This includes planning, execution, documentation. In addition you will contribute to standards and best practices in the validation community. If you are interested in joining a young and dynamic team driving the digital transformation of Bayer Consumer Health, we would like to hear from you.

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.

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.

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 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

We kindly inform that we will only contact selected candidates.

Bayer welcomes applications from all individuals regardless of race, national origin, gender, age, physical characteristics, social origin, disabilities, 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.

At Bayer, we are committed to transparency, equal pay for equal work or work of equal value, and objective reward practices in line with EU and local regulations.

The minimum monthly gross compensation for this role is 20 240 PLN gross with final pay determined based on objective factors such as experience, qualifications, scope of responsibility, and internal alignment.

This position is eligible for variable pay components, such as performance‑based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure.

1 dzień w biurze w Warszawie, 4 dni zdalnie.

20 240 – 25 300 PLN brutto+bonus (18%)+autorskie koszta uzyskania przychodów (70%)

2 etapy rozmów

Digital Hub Warsaw at Bayer

At the Heart of the Digital Hub Warsaw at Bayer lies the agile culture and mindset. Its philosophy and principles are in our DNA and drive the growth and the heartbeat of our organization in order to build and expand the DHub across all six functional divisions: Crop Science, Cyber Security & Risk Management, Consumer Health, Pharma, Enabling Functions and Enterprise Platforms & Innovation. To allow our organization to thrive and grow we embrace a culture of open leadership, people empowerment, people development, diversity and innovation. This approach create a place where creative and innovative minds from the fields of data-science, cyber security software engineering and more, can come together, collaborate, and achieve great things. Here in Warsaw, you can think freely without entrenched hierarchical structures, artificial guidelines and boundaries - mirroring the work culture of a dynamic start-up.

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Twoje dane osobowe będą przetwarzane w oparciu o następujące podstawy prawne: (a) aby podjąć działania na Twoje żądanie przed zawarciem umowy (np. informacje o oczekiwanym wynagrodzeniu i dostępności do rozpoczęcia pracy); (b) w oparciu o nasz prawnie uzasadniony interes (np. imię, nazwisko, data urodzenia, dane kontaktowe, wykształcenie, kwalifikacje zawodowe, przebieg dotychczasowego zatrudnienia); c) w oparciu o Twoją zgodę, która wyrażona jest poprzez przeslanie dokumentów aplikacyjnych zawierających takie informacje jak np. wizerunek czy zainteresowania. Podanie wszystkich danych osobowych, o których mowa powyżej jest dobrowolne, natomiast dane wymienione w lit. a) i b) są niezbędne do wzięcia udziału w rekrutacji. Niepodanie danych skutkuje brakiem możliwości rozpatrzenia kandydatury. Podanie pozostałych danych jest dobrowolne, ale może pomóc w sprawnym przeprowadzeniu procesu rekrutacji. Masz prawo żądać dostępu do Twoich danych (w tym uzyskania ich kopii), sprostowania danych, ich usunięcia, ograniczenia przetwarzania, przeniesienia, jak również wniesienia sprzeciwu wobec ich przetwarzania. Masz także prawo wniesienia skargi do Prezesa Urzędu Ochrony Danych Osobowych. Twoje dane osobowe mogą zostać przekazane dostawcom usługi publikacji ogłoszeń o pracę, dostawcom systemów do zarządzania rekrutacjami, dostawcom usług IT (hosting), dostawcom systemów informatycznych. Podane przez Ciebie dane osobowe nie będą wykorzystywane w celu profilowania albo podejmowania decyzji w sposób zautomatyzowany. Twoje dane osobowe będą przetwarzane przez okres maks. 1 roku od zakończenia publikacji ogłoszenia, chyba, że wyraziłeś odrębną zgodę na wykorzystanie Twoich danych osobowych w przyszłych rekrutacjach. W celu realizacji praw lub w przypadku jakichkolwiek pytań związanych z przetwarzaniem Twoich danych osobowych skontaktuj się z nami pod adresem: Wyświetl e-mail na pracuj.pl.