Description
On behalf of my client, an international biotechnology firm based in Zürich area, Switzerland I am looking for:Chemical Engineer 100% m/f
Responsibilities:
- Apply chemical engineering and chemistry knowledge to support commercial production of my clients API processes.
- Technical oversight for API production ( CMO ) for the companies small molecule products manufactured in their contract manufacturing network
- Detailed analysis and interpretation of production data and information as part of Continued Process Verification, including actions to ensure process performance
- Root cause investigations for non-conformance and out of spec incidents including process impact and corrective action.
- Evaluation of the impact of changes to process inputs, equipment or procedures on process performance and API quality attributes
- Design, development and implementation of process improvements to enhance quality or improve efficiency of processes
- Design of experimental plans at laboratory and/or pilot scale to support issue resolution and improvements
- CAPA and cause investigations
- Technology transfer to manufacturing sites including process performance qualification
- On-the-floor technical support, when required, for successful implementation and execution of process technology or complex investigations
- Technical support for regulatory inspections
- Preparation of technical documents and presentations to cross-functional teams and management
- Travel to Manufacturing sites in Switzerland
Preferred Qualifications:
- Chemist or chemical engineer
- Experience with technical operations to support commercial API production
- Experience introducing, implementing and/or executing chemical API processes in commercial or pilot plants
- Knowledge of API processing equipment, trains and best practices
- Experience working with contract manufacturing organisations
- Experience related to process development, process characterisation, technology transfer, scale-up and/or manufacturing of chemical drug substance (API) processes in a cGMP environment
- Understanding of regulatory and cGMP requirements and trends
- Familiar with analytical chemistry techniques and their application in Quality Control
- Understanding of API solid state characterisation and bulk properties as they relate to drug product performance
- Experience with detailed analysis of data sets and associated process execution documentation (batch sheets, P&ID, Process flow diagrams, CoA's) to identify issues and trends with process performance
- Able to apply engineering principles and statistical analysis, including design of experiments and statistical process control (SPC), in-order to solve processing issues and evaluate opportunities for process improvements
- Experience working in cross-functional teams
- Excellent written and verbal communication in English
About me:
I am a specialised recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word format including your hourly rate expectation for immediate consideration.
For any additional information's you can reach me on or at