Job Description

Monza site is a world-class contract manufacturing and development facility, specialized in aseptic injectable drugs, with an increasing focus on biologics. Joining a distributed team and more than 1500 colleagues on site, the selected candidate will experience an inquisitive, 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 substantial contributions to the world. We believe in a brighter future, and your work will help us get there!

What you will do

You will join a recently-established Manufacturing Process Engineering Team, to provide technical support and expertise to Production and Technology Transfer, and meet the Client’s requests. You will be part of a team of young 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.

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 SME.
• Connect and collaborate closely with the Client, being part of the tech transfer team and process SME
• 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 design and introduce disposable state-of-art technology (SUS)
• Work jointly with Site Engineering and Industrial Engineering to build up the process following client’s requirements, supporting in writing the URS for new equipment.
• Develop and makes recommendations for new process designs and/or modifications of commercial processes to ensure maximum operating efficiency, safety, and compliance with regulatory requirements.
• Manage technical protocols and reports for the engineering 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.
• Review 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 / Industrial Engineering / CTF or similar fields
• Experience with manufacturing processes and equipment in related fields: Pharma Fill & Finish, Pharma Upstream & Downstream, API, Chemical, Food, etc.
• Experience with liquid and lyophilized sterile injectables drugs will be a plus
• Knowledge and understanding of cGMP
• Curious mentality
• Proactivity and willingness to achieve goals despite challenges
• Good communication and interpersonal skills and ability to work in multi-disciplinary teams
• Proficient English and Italian

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.