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Validation Manger (m/f/d) Process & Cleaning Validation

Referenz: 462982001900

on 17 November 2021
Stadt
Biberach
Vertragsart
Festanstellung

Then we are looking for you for a temporary cooperation of initially 12 months, on a project of our customer, a renowned company in the pharmaceutical / biotech industry, in the area of Biberach an der Riss - starting asap.

What you can do for us

  • Assumption of independent responsibility for the support of products within the scope of process & cleaning validation, including representation in interdisciplinary project team or compliance meetings, customer meetings (internal or external customers), and the coordination of validation activities.
  • Validation activities include independent planning of process and cleaning validations including the creation, maintenance and revision of validation documents (validation master plans, validation plans and reports, sampling plans, risk analyses) in coordination with relevant interfaces such as production and analytical areas for process and cleaning validation, primarily in English, including cooperation in the event of associated deviations.
  • Independent research and GMP-compliant evaluation of analytical and operational results and data, e.g. from electronic systems
  • Collaboration on control strategy, risk analysis and other documents in cooperation with the development unit, production, analytical units or other relevant interfaces
  • Evaluation of changes in manufacturing/cleaning processes of products with regard to process and cleaning validation relevance
  • Evaluation of deviations with regard to process and cleaning validation relevance
  • Preparation, maintenance and revision of submission documents including the response to authority enquiries regarding process and cleaning validation
  • Representation of validation topics in audits and inspections
  • If applicable, assumption of the function of change manager with regard to change management
  • If applicable, support of the continuous process verification (so-called Stage III) by evaluation of statistical trending results and participation in the APR/PQR and periodic review.

The skills that are needed

In addition to your CV and important (work)-references, please also submit your workpermit if necessary. Otherwise we will not be able to process your application.
  • Studies in the natural science/technical field (Master's degree) with several years of professional experience or alternatively Bachelor's degree or completed natural science training with many years of professional experience in the GMP environment (pharmaceutical, biotechnology) or the field of process & purification validation, preferably in the production of active pharmaceutical ingredients.
  • Several years of experience in the biopharmaceutical/pharmaceutical/process engineering field, comprehensive GMP knowledge and knowledge of regulatory requirements.
  • Fluent German and very good written and spoken English skills
  • Very good PC skills in the common MS Office applications
  • Experience with SAP and/or TrackWise is an advantage
  • Very high degree of initiative, flexibility and sense of responsibility
  • Independent, structured way of working
  • Assertiveness, communication and team skills, organisational skills and social competence
  • High level of commitment
  • High quality awareness and willingness to acquire process-technical understanding

Why you are in the right place when working with us

We connect the right professionals with the right project, as we do by connecting you with our recruiting projects! Our path together begins with trying to comprehend your ambitions. We shall work together to help you achieve your career objective, by investing in your professional development and mentoring, and by coaching you throughout your career. Modis is a global leader in professional solutions and a dynamic brand with a global focus. We are pursuing ambitious goals in a key market. Our affiliation with Adecco Group opens up a wide array of career choices for you.

You can hardly wait to get to know us? Then a simple click will quickly connect you with us. Just click on "APPLY NOW“ to send us your application.


The future belongs to those who drive innovation, inspire transformation and fuel collaboration. Our commitment is achieved by working together with our clients in combining the key technologies IT, Engineering and Life Sciences in order to develop innovative solutions for the future. We connect top companies with the sharpest minds in Life Science. All of them united by their burning passion to make use of their talents in order to master the challenges ahead. Are you one of them?


Your Contact

Herr Tilman Markowetz

Phone +49 761 38908 213

Modis GmbH
Life Science
Güterhallenstraße 4
79106 Freiburg
www.modis.com

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