For our Headquarter in Ecublens, we are looking for a:Process Engineer (M/F/X) – 100 %Role :As our Process Engineer, you will develop powder handling processes based on customer URS and internal standards.
- €¢ You will perform core engineering calculations, define process parameters, and translate them into equipment specifications and instrumentation requirements.
- €¢ You will also ensure that process designs comply with pharmaceutical industry regulations and standards including GMP, FDA/EMA, PED and ATEX.
- €¢ In this role, you will work closely with Sales, Mechanical, Automation and Project Management teams throughout project execution.Your role :-Process Design & Engineering Calculationso Develop powder handling processes based on customer URS and internal standards.o Perform mass balance calculations.o Conduct flow calculations, pressure drop calculations and hydraulic dimensioning.o Size key equipment including vessels, filters, dryers, piping, valves and pumps.o Define utility requirements including CIP/SIP, nitrogen, compressed air, vacuum and heating/cooling media.-Equipment Dimensioning & Technical Specificationso Translate process parameters into mechanical design requirements.o Define design conditions including pressure, temperature, flow rates and material compatibility.o Prepare and review technical specifications for components and sub-suppliers.o Ensure proper material selection with respect to corrosion resistance, cleanability and GMP compliance.-Instrumentation & Control Definitiono Define the process instrumentation philosophy including flow, pressure, temperature and level measurement.o Specify sensors, transmitters, control valves and safety devices.o Contribute to the definition of the control strategy with automation engineers.o Support alarm management and interlock logic definition.o Ensure instrumentation complies with GMP and hazardous area requirements (ATEX if applicable).-Regulatory Compliance, Risk & Documentationo Integrate GMP, FDA, ATEX, PED and industry standards into the process design.o Perform or contribute to risk analyses including FMEA and HAZOP.
- €¢ Support validation documentation including Design Qualification and contributions to IQ/OQ.o Prepare and maintain process documentation including PFDs, P&IDs and functional descriptions.o Ensure traceability and documentation quality according to pharmaceutical standards.-Project Execution & Cross-Functional Collaborationo Support Sales and Project Managers during feasibility studies and technical clarifications.o Participate in design reviews with mechanical, automation and manufacturing teams.o Support Project Managers during project execution as process design owner.o Participate in FAT and SAT when required to ensure process performance compliance.o Support troubleshooting of technical issues during commissioning and startup.Your profile :Bachelor’s or Master’s degree in Chemical Engineering or Process Engineering.
- €¢ Mechanical Engineering background can be accepted.3–7+ years of relevant experience in pharmaceutical or chemical process engineering.Background in regulated environments (GMP required).Strong knowledge of powder transfer and handling including filtration, drying, mixing, milling and containment systems.Parcours professionnel with mass balance calculations, flow and pressure drop calculations, equipment sizing and pipe dimensioning.Expertise with instrumentation specification.Ability to develop and interpret PFDs and P&IDs.Knowledge of GMP, FDA/EMA, PED and ATEX.Familiarity with risk analysis methods such as FMEA and HAZOP.Strong analytical skills and proficiency in Excel.Understanding of process scale-up and industrial equipment integration.Fluent English (spoken & written).Willingness to travel to DEC sites or customer sites on a regular basis (10–15%).