Manufacturing Process Engineer - Msat

Follow all the technology transfer phases from the initial project Kick-off to the process implementation as a technical operations SME.Connect and collaborate closely with the ClientDevelop process flow diagrams, establish technical fit into existing facilities & equipment, identify process, facility, and safety gaps with efficient technical solutions, implementation timing with assumptions, and alternative to be considered.Connect with suppliers to craft and introduce disposable state-of-art technology (SUS - single use systems technologies)Work jointly with other Engineering departments to build up the process following the client's requirements, supporting in writing the URS for new equipment.Develop and make recommendations for new process designs and/or modifications of commercial processes to ensure maximum operating efficiency, safety, and compliance with regulatory requirements.Lead technical protocols and reports for the trials of the new products.
Ensure that the related activities are performed accurately on the shop floor.
Provide support for potential quality investigations and mitigation actions definition and implementation.Provide support to Production on operating problems and to maintenance/plant engineering on equipment performance and materials problems.
Provide technical recommendations to permit plant operation within regulatory requirements (FDA, EMEA, AIFA, etc.
).Provide technical support to departments outside Production.
How you will get thereMS in Chemical Engineering / Industrial Engineering / CTF or similar fieldsExperience with manufacturing processes and equipment in related fields: Pharma Fill & Finish, Pharma Upstream & Downstream, API, Chemical, Food.Experience with liquid and lyophilized sterile injectables drugs is a plusKnowledge and understanding of cGMP Curious mentalityProactivity to achieve goals despite challengesGood communication and social skills and ability to work in multi-disciplinary teamsVery good level of English (spoken and written) and Italian