ph3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 h3MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES: /h3 pThe Manufacturing Process Expert will serve as an advanced root cause analysis expert in support of a cross-functional team that is focused on problem-solving and continuous improvement for the site. The investigation team is a key part of the Technical Unit organization. It is focused on driving quality excellence, prevention of error and deviations, continuous improvement, and effective problem-solving. The Manufacturing Process Expert is responsible for facilitating and performing advanced root cause analysis to solve complicated technical problems and completed investigation. /p h3ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES: /h3 ul lipbInvestigations /b /p /li lipManagement of deviations, in collaborations with cross functional team /p /li lipInvestigation plan definition /p /li lipGuide and/or execute the Root Cause Analysis for deviation events and guide the definition of CAPA with cross functional team /p /li lipExecute Technical Analysis inside and outside the Technical Unit /p /li lipCoordinate a cross functional investigation team inside and outside the Technical Unit /p /li lipUtilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations /p /li lipbTechnical process knowledge /b /p /li lipSupports Manufacturing in the implementation of Corrective and Preventive actions (CAPA) in collaboration with Quality Specialist (QS).



/p /li lipProactively identify and mitigate risks. /p /li lipSharing of lessons learned during the Technical Unit huddles /p /li lipbAudit /b /p /li lipUtilizes manufacturing process knowledge and investigation skills during client and Regulatory audit for the deviation assigned /p /li lipbMethodology/KPI /b /p /li lipContribute to achieving "zero past due" objectives in Quality (CAPA, Deviations) within one's scope of responsibility, as well as RFT (Right First Time) and OTIF (On-Time In Full) objectives for document submission to the client and lot release. /p /li /ul h3RELATIONS: /h3 h3Internal /h3 ul lipAll functions and seniority levels including Site Leadership Team /p /li lipSupervisor Quality Manufacturing /p /li lipTU assigned employees (operators, lead, team leaders, SPVs, tech team) /p /li lipQuality Function /p /li /ul h3External /h3 ul lipCorporate functions /p /li lipEmployees from other Thermo Fisher Scientific sites /p /li lipCustomers /p /li lipConsulting firms /p /li lipSuppliers /p /li /ul h3REQUIREMENTS /h3 ul liDegree in Chemistry/ CTF/ Biological Sciences or similar fields /li /ul h3Desirable /h3 ul liExperience in Quality Assurance Operations teams,



with a focus on deviation management and support to GMP manufacturing. Excellent knowledge of GMP and national/international regulations /li /ul h3Technical competences: /h3 h3Necessary /h3 ul lipAbility to function in a fast paced, dynamic environment with multiple priorities simultaneously. /p /li lipStrong interpersonal and communications skills; written and oral. /p /li lipGood knowledge of cGMP. /p /li lipMust be skilled in meetings and interviews to eliciting technical details from subject matter experts. /p /li lipMust be skilled in the use of a personal computer and related software applications, Trackwise strongly desired. /p /li lipAbility to write, handle and review GMP documentation (Deviations, CAPAs…) and understanding of main quality indicators. /p /li lipKnowledge of injectable sterile process manufacturing. /p /li /ul h3Desirable /h3 ul lipSolid understanding of root cause analysis tools, TapRoot preferred. /p /li lipStrong planning, organization and multitasking skills. /p /li lipGood knowledge of TrackWise system /p /li /ul h3Professional Experience: /h3 h3Necessary /h3 ul liExperience within manufacturing industries /li liFluency in English and Italian /li /ul pThermo 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. /p /p #J-18808-Ljbffr

📌 Manufacturing Process Expert (Monza)
🏢 Thermofisher Scientific
📍 Monza