Monza site is a world class contract manufacturing and development facility, specialized in aseptic injectable drugs, with an increasing focus on biologics. Joining a global team and more than 1500 colleagues on site, the selected candidate will experience a smart, international, and fast-growing environment. With revenues of more than $30 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
What you will do
You will join a newly-established Manufacturing Process Engineering Team, to provide technical support and expertise to Production and Technology Transfer, to meet Client’s requests.
In this role you will lead client’s projects from a technical standpoint for what concern 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 state-of-the-art equipment, your technical support will be essential in manufacturing new life-saving sterile drugs.
A hands-on, goal-driven attitude will be key in exceeding client’s expectations, and the ability to “think out of the box”, coupled with a strong technical mindset, will help you in troubleshooting and finding new solutions to problems.
Follow all the technology transfer phases from the initial Kick off to the shop floor process implementation as technical SME.
Develops process flow diagrams, establish technical fit into existing facilities & equipment, identify process, facility and safety gaps with cost effective technical solutions, implementation timing with assumptions, and alternative to be considered.
Connect with suppliers to design and introduce disposable state-of-art technology (SUS)
Works jointly with Site Engineering and Industrial Engineering to build up the process following client’s requirements, supporting in writing the URS for new equipment.
Develops and makes recommendations for new process designs and/or modifications of commercial processes to ensure maximum operating efficiency, safety and compliance with regulatory requirements.
Manages technical protocols and reports for the engineering trials of the new products. Ensure that the related activities are performed properly on the shop floor. Provide support for potential quality investigations and mitigation actions definition and implementation.
Provides manufacturing process engineering support to Production on operating problems and to maintenance/plant engineering on equipment performance and materials problems.
Provides technical recommendations to permit plant operation within regulatory requirements (FDA, EMEA, AIFA, etc.).
Provides technical support to departments outside Production.
Reviews all process designs and modifications for safety implications and requirements. Promotes a safe work environment for self, and other personnel to reduce personnel and environmental health and safety (EH&S) risks.
How you will get there
MS in Chemical Engineering / Process Engineering / CTF or similar fields
Experience with manufacturing process and equipment, preferably with liquid and lyophilized sterile injectables drugs
Strong technical mindset and problem-solving skills