Overview
We are currently seeking a Validation Manager* to strengthen our global IT team. You will work in an interdisciplinary environment with colleagues from Tübingen, Munich and Houston. You will work on-site in Tübingen (Germany) and in addition we offer flexible work from home options. Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.
Your mission
Your main responsibilities will include but are not limited to the following tasks:
- Manage the selection and implementation of software products that produce and store GxP relevant data.
- Ensure systems meet FDA regulations and data integrity standards.
- Work with other departments to mitigate risks using technical, procedural and administrative controls.
- Manage timelines and prioritize projects based on guidance from senior management.
- Teach project management, FDA regulations and technical expertise skills to junior employees.
- Teach and promote a culture of compliance through educating stakeholders and end users on the validation process, regulations and system requirements.
- Author, review and execute validation documents throughout the qualification process.
Your profile
You hold a bachelor’s degree in science, engineering or a related field. You have worked in a validation role for 5+ years and have experience in the pharmaceutical industry within a fast-paced environment with minimum supervision (Biotechnology preferred). You are familiar with the principles of good documentation practices and data integrity principles and have an understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, GAMP 5 and USP <1058>.
We expect a high degree of independent working, analytical reasoning and excellent communication skills in English and preferably German. You embrace rapidly changing requirements with an ability to make sound decisions and approach problems with curiosity and open-mindedness. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.
Why us?
We are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
Notice
*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
About Us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.
This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
