Genmab - Senior Quality Engineering Architect, Test & Validation

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

Join Genmab's extra[not]ordinary™ IT & Digital organization in transforming patient care through innovative technology solutions. We are looking for a skilled Senior Quality Engineering Architect, Test & Validation to drive the automation and enhancement of GxP workflows across our supported products and platforms, focusing on life sciences' critical environments. 

The Role

As a Quality Engineering Architect at Genmab, you will be instrumental in designing, implementing, and leading all aspects of the validation and testing architectures for our extensive portfolio of research and clinical development platforms. This includes but is not limited to Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), Quality Document Management Systems, and Medidata EDC Rave. 

This role is hybrid, which means you have to be on-site 60% of the time and can be working from our HQ in Copenhagen, Denmark or our site in Utrecht, The Netherlands.

Key Responsibilities

• Develop and enhance automated test frameworks, API monitoring and CI/CD pipelines using tools such as Groovy, Yaml, Ant, Shell scripting, Ready API, Maven, NodeJS, Bash scripting, and Fortify. 
• Design test strategies specifically tailored for AI/ML products, Cloud service architectures, Data Engineering solutions, and Data-as-a-Product offerings. 
• Implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) within the Test Validation Framework to ensure compliance and integration in product releases. 
• Collaborate multi-functionally with IT teams and business partners to define and improve test strategies, frameworks, infrastructure, tools, and coverage. 
• Lead the documentation and tracking of defects using tools like JIRA or HP QC. 
• Conduct research and analysis to select appropriate tools, automation frameworks, and methodologies for improving testing processes. 

Why Join Us?

At Genmab, you will be part of a pioneering team dedicated to developing innovative solutions that empower healthcare transformation. You will work in a challenging and rewarding environment where your contributions directly influence patient outcomes. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth. 

Join Genmab and be at the forefront of creating an impact where it matters most. 

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. 

Requirements

• Bachelor’s or master’s degree in computer science, Engineering, Information Systems, or a related field. 
• Proficiency in CI/CD pipelines, functional, API, Security and performance testing.
• Proven experience in a solution automation architect role, preferably within a GxP-regulated Life Sciences environment, but this is not must.
• Expertise in relational databases and performance SQL scripting. 
• Familiarity with XML, Java libraries/frameworks such as CXF, JAXB, and Spring. 

Certifications (Desirable): 

• ISTQB, PMP, ISEB, SAFE, AWS, AZURE, QAI, ITIL, CISSP, CSQE 

Skills

• Proficient with API/web services testing using tools like Postman, SoapUI, and ReadyAPI. 
• Experience with build and CI/CD tools like Gitlab, Jenkins, Teamcity, and Maven. 
• Strong background in data reconciliation validation, security testing, virtualization technologies, and containerization. 
• Knowledge about system integration and cloud service architecture, such as Gitlab plug-ins to selenium and datalakes (AWS and Azure) And Atlassian enterprise platform.
• Hands-on experience with test automation tools such as Tricentis, Selenium and Cucumber and other automated data validation frameworks. 

Experience

• Minimum 7 years in OO software development/architecture, preferably Java. 
• Extensive experience in automated testing and familiar with commercial tools like Rational Quality Manager. 
• Experience with orchestration engines, workflows, BPMN, and mocking frameworks is highly advantageous.