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Job Description

What Makes This Opportunity Unique

As a Manufacturing Process Engineer at our Monza site, you will be part of an innovative team dedicated to innovation and exploration. You’ll work in a powerful facility specializing in aseptic injectable drugs, helping to manufacture life-saving sterile drugs.

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 passionate professionals, collaborating to drive technical success in manufacturing activities. Your hands-on approach and ability to think creatively will be crucial in exceeding client expectations and solving complex problems.

Responsibilities

• Attend all technology transfer phases from initial project kick-off to 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, and identify gaps (process, facility, and safety) with efficient technical solutions and alternatives to be considered.

• Connect with suppliers to develop and introduce brand-new technology (SUS - single-use systems technologies).

• Work jointly with other engineering departments to build up the process following the client’s requirements, writing the URS for new equipment and processes.

• 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 (FDA, AIFA, etc.)

• Lead technical protocols and reports for the trials of new products. Ensure that related activities are performed accurately on the shop floor. Provide support for potential quality investigations and mitigation actions definition and implementation.

• Analyze data with statistical tools to better understand the processes.

• Support production on operating problems and maintenance/plant engineering on equipment performance and materials problems.

How You Will Get There

• MS or equivalent experience in Chemical Engineering, Industrial Engineering, CTF, Biotechnology, or related 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 injectable drugs is a plus.

• Knowledge and understanding of cGMP.

• Curious mentality.

• Proactivity and ability 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.

Benefits

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.

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.