Experience Confirmed (4-5 years)
Our client, one of the world´s leading pharmaceutical company, is currently looking for their future Methods Engineer.
- Provide technical leadership to identify, evaluate, and improve existing manufacturing processes.
- Collaborate for an effective development activity with Quality, R&D, Analytic, Validation group, Engineering Facilities and various vendors to develop and sustain manufacturing processes…
- Evaluate in collaboration with PPD if new or improved processes are compatible with the company manufacturing facilities and equipments. You will participate to first production batches and validate the transfer from PPD to manufacturing team.
- Provide support to new proOur client, one of the world´s leading pharmaceutical company, is currently looking for their Project Manager – Product Process Development.duct introduction, production process development, product transfers, and existing process sustainment.
- Manage the design and execution of manufacturing process (Preparation, Synthesis, Dialysis, degassing filling, sterilization, final packaging) and appropriate Verification/validation activities accordingly applicable procedures and regulations.
- Develop and/or review/approve documentation to support improved manufacturing processes per applicable procedures.
- Write and perform Validation plan strategy and process validations in collaboration with Validation team including methods for inspection.
- Participate to Risk process analysis and propose appropriate recommendations to mitigate risks.
- Work cross functionally with R&D, PPD and Quality to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals (CAPA/ NCRB/ DCC meetings).
Your profile :
- Engineering degree or equivalent.
- At least 5 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.
- lndustrial experience working in a GMP compliant setting.
- Experience leading cross-functional teams in the improvement and scale up of manufacturing processes.
- Experience with regulatory filings for Medical Devices and supporting regulatory inspections
- Project management in international environment focused on results.
- French -English speaking.