MS&T Process Engineer (m/f)
(Temporary for 24 months)
Are you ready to dive into the deep end of development and production of global commercial biological drug products and their life cycle development? Then come on board and join our Technical Support Team that works in close cooperation with the divisions Technical Operations and Quality.
Your scope of duties:
You will use your targeted expertise in the Technical Support for completing retrospective and prospective QbD for drug product through data/information mining related to formulation/process development and characterization history, drug product manufacturing process history including process validation, and regulatory submission history.
You will also provide technical assistance in discussion, studies and report writing for completion of the key QbD deliverables including detailed process description (DPD), product impact assessment (PIA), historical process characterization summary, process validation master plan (PVMP), gab assessment, additional process characterization as required, parameters classification and process control and analytical strategy and update the DPD as needed.
With strong commitment you will also take the helm and implement process characterization studies, scale down studies, studies in support of process improvement technology transfers and comparability studies and assessments.
As a key member in QbD activities for drug product (Stage 1 Process Validation) you handle established equipment as fermenters, high pressure homogenizers, tangential flow filtration units, chromatography columns and different types of centrifuges. Furthermore you take up a leading role in the CPV program.
- Process engineering support of technology transfers and engineering capital projects
- Monitoring and trending of process data
- Lead product impact assessments in support of investigations and CAPAs
- Collaboration with peers in the continuous improvement of process, including standards, practices, specifications, procedures and business processes
- You have a Bachelor‘s degree in Chemistry, Biochemistry, Pharmaceutical Science, Chemical engineering or related scientific or technical discipline from accredited Technical University, MSc with appropriate experience would be accepted
- You have a wide understanding of cGMPs, industry and regulatory standards and guidelines, strong ethical foundation, and your knowledge and understanding of the scientific principles and concepts in chemical & pharmaceutical sciences is above-average
- You are fluent in English speaking and writing. Fluency in the language of the site, German, is desirable
- You must be experienced in relevant technical and cross-cultural leadership in the pharmaceutical industry, including manufacturing plant experience (minimum of 3 years!)
- You impress with good interpersonal skills coupled with demonstrated networking capacities allowing to effectively working in a matrix organization
- You are a Self-Starter, able to work with supervision in a matrix environment and pay attention to technical details
- You are well versed in identifying potential issues and developing creative solutions to technical problems in order to keep projects on schedule
Are you ready to work in a challenging, but also dynamic and growing environment?
Then take the chance and make a difference in a position that gives you room to grow. We offer a competitive compensation package including benefits, a flat hierarchy and many opportunities for professional development. We look forward to hearing from you.
Please submit your application online.