QM Validation Engineer (m/f/x)

Job description

At LenioBio, we believe every person should have the opportunity to live a healthy and productive life. We have one goal: to simplify manufacturing and speed up drug delivery to the patient.

We are in the midst of an incredible journey. Our ALiCE® technology scales with the pharmaceutical R&D process: from discovery to product testing and clinical trials, and finally to GMP-grade production in the form of an end-to-end integrated production platform.

We are looking for passionate individuals that share our mindset of curiosity and commitment to add their knowledge to the team. Do you want to be part of our journey? Then please keep reading!


About this job

At the next possible starting date, we are looking for a committed QM Validation Engineer (m/f/x) who combines risk based thinking and accurate working with strong communication skills and a solution focused mentality. As our dream candidate you bring practical experience in Quality Management and are thrilled to contribute with your knowledge and hands-on attitude to our ambitious quality targets.

Your daily work includes close cooperation with the different areas of the company. Therefore, you are in constant exchange with operations, Quality Control and production. Additionally, you are involved in training of employees as well as in the processing of deviations, change controls and Corrective and Preventive Actions (CAPA). You report to the Quality Manager and assist her in the implementation, maintenance and improvement of the Quality Management System.

Your responsibilities are:


  • Conduction of risk analyses (FMEA) relating to new production processes and analytical methods
  • Implementation and maintenance of a validation concept
  • Coordination of qualification and validation activities
  • Creation of qualification and validation documents
  • Review and evaluation of qualification and validation results
  • Support the implementation of a new QMS software

Job requirements

Requirements

This job will suit you best if you

  • have a completed scientific study or completed technical/scientific vocational training with professional experience in the field of process or method validation
  • bring a minimum of 5 years relevant industry experience in a Quality (QM, QA and/or QC) or production environment
  • have very good GMP knowledge and knowledge of regulatory requirements
  • have a very good knowledge in coordination and implementation of qualification/validation activities
  • take risk based decisions
  • like processing and evaluating deviations, change controls & CAPA
  • enjoy creating and reviewing QMS relevant documentation
  • have good communication skills to versatile audiences


What we offer

  • full-time, permanent position located in Aachen. In the mid-term, we will be merging the Head Office in Düsseldorf and our Technology & Innovation Center in Aachen in a new company building in the Düsseldorf / Cologne / Aachen region.
  • opportunity to join an international, innovative and fast-growing biotech company, with excellent career development opportunities, where you can develop yourself professionally and have a real impact in the company from day one
  • competitive salary
  • high level of freedom and responsibility
  • a great diverse and international team of dedicated, open-minded colleagues


Who we are

LenioBio is a biotech company that develops and markets a novel and proprietary protein production platform, ALiCE®, which enables protein-based therapeutics to become more accessible and affordable. LenioBio was founded in 2016 in Germany to broadly commercialize the ALiCE® platform, originally developed by DowDuPont and the Fraunhofer Institute IME.

Winning the prestigious Horizon 2020 grant in 2019 enabled our accelerated growth and our primary focus is to scale the ALiCE® technology to industrial scale.


Our principles

All our activities are driven by our core values. Bring them to life with us!

  • Fearless in our commitment
  • Respect is in our DNA
  • Only united can we excel
  • Simply caring for the better
  • Driven to learn, grow and progress

Have we triggered your interest? Then we are looking forward to your application in English.*

Do you have any questions up front? Please feel free to contact Dr. Severine Schröder at: +49 1590 4008706.


*Applications through recruiters will not be considered.