Process Engineer CMC

Posted 02 November 2021
ArbeidstedOslo
Job type Fast
KategoriLife Sciences
ReferenceBBBH491708_1635856812

Job description


SoftOx Solutions AS is a Norwegian BioTech company registered at Euronext Growt Oslo. The company's vision is "Helping The World Figthing Infections" by developing new ways of battling infections and antimicrobial resistance. SoftOx works to fight threats towards human health, including the fight against multiresistant bacteria (AMR), biofilm infections in chronic wounds, and the spread of viruses.

For more information about SoftOx, visit https://soft-ox.com/


We are growing and are looking for a Process engineer, CMC (Chemistry, manufacturing, and control)

The process engineer CMC will work with production of Soft-Ox product portfolio but will also work as a support for other departments, such as sales, marketing, production and GMP/QA. This position will be involved in the companies Biocide application and GMP production, practical production issues and daily sales and marketing regulatory questions. You will also help QA with complaints and SOP writing and many other daily challenges occurring in the CMC department.

This is an opportunity for a highly motivated and skilled engineer to work in a fast-paced organisation contributing to sustainable solutions for the hand disinfectants and drugs to make an impact on world health.

Tasks together with CMC-team:

  • Responsible for building up GMP production at Fornebu site
  • Equipment qualification and documentation
  • Process development and validation - planning, conducting, and reporting experiments
  • Participate in production support activities and trouble shooting
  • Evaluation of changes and non-conformities in relation to production
  • Produce test formulations in laboratory and manufacturing scale for internal and external testing
  • Prepare, perform, and report stability studies for new and existing products
  • Lead or participate in technology transfer projects for new formulations or in connection with moving of production to new sites and follow up production externally
  • Writing documentation, i.e. SOPs (Standard Operation Procedures), plans or protocols, reports etc.
  • Prepare applications to authorities for biocides and follow up



We believe you have the following background:

  • Master of Science or equivalent within process chemistry
  • Experience with GMP, ISO-13485 and Biocide regulations and excellent skills in Quality documentation is an advantage
  • Practical experience from production and having built a production is an advantage
  • Experience and knowledge in selection, testing and use of process equipment i.e. batch reactors and filling equipment
  • Knowledge in using statistical experimental design and data analysis tools is an advantage
  • Fluent in both spoken and written English. One Scandinavian language is a bonus
  • Experience with preparation of documentation for biocides, medical devices, or drugs is an advantage


If you find this interesting, we encourage you to apply, even if you have just recently finished your education.

We can offer you this:
An exciting role in a Norwegian start-up company, with ample opportunity to take part in building up a company and leave an impact. Challenging and varied tasks in an informal and creative organization. Competitive salary and benefits.



For questions regarding the position, please contact Kelly Scientific, Consultant Kristina Skants on +47 406 07 346 or Branch Manager Thomas Lund on +47 401 08 070. Kelly Life Sciences is a recruitment agency, specialized in positions in the Life Science Industry in Norway.

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