Job Description
What you will do
You will join the Manufacturing Process Engineering Team, to guide Production for Technology Transfer Projects, and meet Client's requests. You will be part of a team of energetic and passionate professionals: we are waiting for you!
In this role you will lead client's projects from a technical standpoint for what concerns the manufacturing activities, assisting Technology Transfer Project Managers on customer technical transfers, modifications to existing processes, or adding new processes that will improve process safety, reduce plant operational costs as well as improve product quality and efficiency. Working with innovative equipment, your technical support will be critical in manufacturing new life-saving sterile drugs.
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A hands-on, driven approach will be key in exceeding clients' expectations, and the ability to "think out of the box", coupled with a strong technical approach, will help you in solving issues and finding new solutions to problems.
Responsibilities
- 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 Client
- Develop 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 there
- MS in Chemical Engineering / Industrial Engineering / CTF or similar fields
- Experience 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 plus
- Knowledge and understanding of cGMP
- Curious mentality
- Proactivity to achieve goals despite challenges
- Good communication and social skills and ability to work in multi-disciplinary teams
- Very good level of English (spoken and written) and Italian