Manufacturing Process Expert

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES:** The 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. **ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES:** * **Investigations** * Management of deviations, in collaborations with cross functional team * Investigation plan definition * Guide and/or execute the Root Cause Analysis for deviation events and guide the definition of CAPA with cross functional team * Execute Technical Analysis inside and outside the Technical Unit * Coordinate a cross functional investigation team inside and outside the Technical Unit i * Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations * **Technical process knowledge** * Supports Manufacturing in the implementation of Corrective and Preventive actions (CAPA) in collaboration with Quality Specialist (QS). * Proactively identify and mitigate risks. * Sharing of lessons learned during the Technical Unit huddles * **Audit** * Utilizes manufacturing process knowledge and investigation skills during client and Regulatory audit for the deviation assigned * **Methodology/KPI** * Contribute 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. **RELATIONS:** **Internal** * All functions and seniority levels including Site Leadership Team * Supervisor Quality Manufacturing * TU assigned employees (operators, lead, team leaders, SPVs, tech team) * Quality Function **External** * Corporate functions * Employees from other Thermo Fisher Scientific sites * Customers * Consulting firms * Suppliers **REQUIREMENTS** * Degree in Chemistry/ CTF/ Biological Sciences or similar fields Desirable * Experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturing Excellent knowledge of GMP and national/international regulations **Technical competences:** Necessary * Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously. * Strong interpersonal and communications skills; written and oral. * Good knowledge of cGMP. * Must be skilled in meetings and interviews to eliciting technical details from subject matter experts. * Must be skilled in the use of a personal computer and related software applications, Trackwise strongly desired. * Ability to write, handle and review GMP documentation (Deviations, CAPAs…) and understanding of main quality indicators * Knowledge of injectable sterile process manufacturing Desirable * Solid understanding of root cause analysis tools, TapRoot preferred. * Strong planning, organization and multitasking skills. * Good knowledge of TrackWise system **Professional Experience:** Necessary * Experience within manufacturing industries * Fluency in English and Italian