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Senior Process Engineer (m/w/d) Product Coordination Life Cyle

Referenz: 463774001900

on 17 November 2021
Stadt
Biberach
Vertragsart
Festanstellung

Then we are looking for you for a temporary cooperation of initially 24 months, on a project of our customer, a renowned company in the pharmaceutical / biotech industry, in the southern perimeter of Ulm.

What you can do for us

  • In your new role, you will be responsible for the supervision of national and international projects within the scope of the life cycle for the area of "Product Coordination Life Cyle G104", including interface management, customer support and support during inspections/audits. As a line representative, you will make decisions in the interdisciplinary project teams.
  • You will ensure campaign readiness for smooth production by processing investigations from deviations, implementing CAPAs and changes in a timely manner using various tools of the pharmaceutical quality system.
  • Continuously analyse and improve production processes and workflows through process monitoring, trend analysis and statistical evaluations of process anomalies. Leading or participating in trouble shootings, troubleshooting and operational excellence projects. Standardised statistical analysis procedures are established and further developed.
  • The evaluation, interpretation, assessment and preparation of process data and key figures for the customer and the relevant interfaces are also part of your area of responsibility, as is communication and coordination with customers in the context of campaign/product support.
  • For regulatory relevant GMP documents (Qualification, Validation, Annual Product Review, Continued Process Verification, Marketing Authorisation Application, Variation, Request for information) you will ensure that the initiation, preparation, review and follow-up is done on time.

The skills that are needed

Please submit your CV and important (work) references, your certificate of completion, if required, as well as your work permit. Otherwise we will not be able to process your application.
  • Degree in natural sciences with several years of work experience or advanced technical education with many years of work experience in relevant work environments/areas
  • Several years of professional experience in the field of biotechnology with knowledge in cell cultivation or development of biopharmaceuticals as well as GMP understanding
  • Good knowledge of data visualisation (e.g. using Spotfire) and willingness to further develop existing programming
  • Affinity for statistical analysis including the use of appropriate software (e.g. using SIMCA)
  • Ability to independently identify/process/solve problems including analysis of complex interrelationships
  • Working in a matrix structure requires a high level of professional and social competence, motivation and teamwork skills and a high level of commitment
  • Technical leadership of interdisciplinary teams
  • Fluency in English for successful communication with international partners and authorities is a prerequisite

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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