Working @ Immatics

Senior Manager, Validation

Permanent employee, Full-time · Houston (TX)

Overview
Support Immatics’ corporate initiative to digitalize clinical, quality management and manufacturing processes. 
Your mission
Essential functions: 
  • Plan and perform validation of GxP-relevant computerized systems 
  • Create all computerized systems validation documentation including validation plans, test plans, risk assessments, systems specifications, validation reports, etc 
  • Work closely with Immatics’ and vendor’s project management teams to ensure that the deliverables are configured and/or customized as set forth in the relevant system specifications 
  • Create SOPs, working instructions and other system documents in collaboration with subject matter experts, as required 
  • Support data migration activities between legacy and new systems, as required 
  • Deliver trainings, as required 
 
Secondary functions: 
  • Conduct quality reviews for validation documents delivered by internal stakeholders and/or external third parties 
  • Support Immatics in case of GxP regulatory inspection in regard to validation processes 
Your profile
Required education and experience 
  • Bachelor’s degree in natural sciences, engineering, or a related field 
  • Subject matter expert in the validation of computerized systems in the GxP pharmaceutical or medical devices industry 
  • Minimum of 5+ years of experience in working or consulting for life science companies in validation engineering positions 
  • Versed in GMP and/or GCP regulatory requirements 
  • Fluent in written and spoken English  
 
Preferred education and experience 
  • Good understanding of Quality Assurance thinking and work  
  • Knowledge about ISO13485 standard and/or FDA 510(k) is a plus 
  • Speaking German is an asset 
 
Additional eligibility requirements
Familiar with intercultural work (USA-Europe); ability to work independently with an elevated level of individual responsibility, enthusiasm, and strong social skills. Motivation is driven by the passion for your work.
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. Immatics offers partial subsidized health, dental and vision insurance, 401(k), generous PTO, paid holidays, paid parking, paid short/long term disability/AD&D, life insurance and stock options. 
Notice
Recruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@immatics.com, and we will contact you if needed.  
 
Immatics values 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.