Manufacturing Process Expert

Job description

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