MSAT Process Engineer

Ready to further expand your expertise in an environment where variation and growth are central?

At Maandag, it is all about people and their development. We connect talent with challenging projects within various sectors. This gives you the opportunity to discover different environments, deepen your skills, and step by step shape your own career path, always with a team behind you that thinks along with you. And today? Today, together with one of our clients, we are looking forward to an MSAT Process engineer for a project within the chemical sector.

The Manufacturing Science, Analytical and Technology (MSAT) department forms the scientific and technical backbone of the organization. The department supports commercial production and is responsible for, among other things, the optimization of processes and methods throughout their entire lifecycle (lifecycle management), the technology transfer of new products, processes, and methods, and the development of innovative, robust, and cost-efficient processes and methods of the next generation.

Drawing on strong scientific and technical expertise, you will actively contribute to Technology Transfer activities, supporting the introduction of new products and processes within production environments. Additionally, you will work on improvement initiatives and the continuous follow-up and monitoring of existing processes.

The role focuses primarily on production activities on an industrial scale within cell culture or purification. At the same time, you will work closely with laboratory teams for activities and studies on a laboratory scale.

• You support the introduction of new production processes for drug substances (active pharmaceutical substances) by guiding the technology transfer from development laboratories to large-scale GMP production facilities. In doing so, you ensure that the necessary documentation is available and ready in a timely manner. This includes, among other things, performing process fit-gap analyses, defining process control strategies, preparing media batch sheets and sampling plans for the production of clinical batches. Additionally, you provide support during the Process Performance Qualification (PPQ) to successfully implement new processes on a production scale.
• You identify and lead process improvement initiatives with the aim of increasing the yield, efficiency, and robustness of production processes. You collect and analyze scientific and technical data and compile supporting data packages to enable the implementation of improvements on a production scale.
• You provide continuous scientific and technical support to existing commercial production processes. This includes, among other things, data trending and process monitoring, drafting scientific and technical study protocols and reports to support important process changes, and contributing to investigations and process and product impact assessments during significant deviations during production.
• You hold a PhD or master's degree in Life Sciences and have relevant experience within process development, MSAT, or a similar role. For a PhD, a minimum of 3 years of relevant experience is expected, and for a master's degree, a minimum of 5 years.
• You are fluent in English, both orally and in writing, so that you can function effectively within an international working environment.
• You have practical experience with mammalian cell culture and/or purification processes on a laboratory and/or production scale.
• You are flexible and can adapt to changing working conditions. This includes the willingness to work occasionally in the evenings or on weekends if necessary and to provide support for both small-scale laboratory studies and larger-scale production activities.
• You are a true team player who collaborates effectively within multidisciplinary teams and is able to build constructive and lasting working relationships.
• You can handle changing priorities well and know how to adapt quickly within a dynamic working environment.
• You possess strong interpersonal and communication skills. You easily establish contact with colleagues, can facilitate discussions, and are able to reach workable compromises and solutions together with other departments or teams.
• You work accurately and are detail-oriented, possessing strong analytical skills to identify, investigate, and approach challenges and problems in a targeted manner.
• You are familiar with statistical analyses and data-trending techniques. Experience with software such as JMP, Statistica, Matlab, or Simca is a plus.
• You have good knowledge of the applicable Good Manufacturing Practices (GMP). Previous practical experience within a GMP environment is an additional asset.