Process Manufacturing Expert

Overview

Work Schedule: Standard (Mon-Fri)

Responsibilities

• 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 focused on problem-solving and continuous improvement for the site. The investigation team drives quality excellence, prevention of errors and deviations, continuous improvement, and effective problem-solving. The Manufacturing Process Expert facilitates and performs advanced root cause analysis to solve complicated technical problems.
• ASSIGNMENTS, SPECIFIC / PRIMARY ACTIVITIES:
  • Investigations: management of deviations in collaboration with cross-functional team
  • Investigation plan definition
  • Guide and/or execute 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
  • Lead cross-functional investigation team inside and outside the Technical Unit
  • Utilize manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
  • Technical process knowledge / Production
  • Support Manufacturing in the implementation of Corrective and Preventive Actions (CAPA) in collaboration with Quality Specialist (QS)
  • Proactively identify and mitigate risks
  • Share lessons learned during Technical Unit huddles
  • Audit: participate in client and regulatory audits for the assigned deviation, using manufacturing process knowledge and investigation skills
  • Methodology / KPI: contribute to achieving zero past due objectives in Quality (CAPA, Deviations) and other objectives such as Right First Time (RFT) and On-Time In Full (OTIF) for document submission to the client and lot release
• RELATIONS:
  • Internal (alcuni esempi): All functions and seniority levels; Direct report of Qop Manufacturing Supervisor; Collaboration with Quality Specialist of the TU
  • External (alcuni esempi qui sotto): Corporate functions; Employees from other Thermo Fisher Scientific sites; Customers; Consulting firms; Suppliers

Requirements

• Education
  • Necessary: 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; Strong interpersonal and communications skills; Thorough knowledge of cGMP; Ability to write, handle and review GMP documentation (Deviations, CAPAs); Knowledge of injectable sterile process manufacturing
  • Desirable: Solid understanding of root cause analysis tools (TapRooT preferred); Strong planning, organization and multitasking skills
• Professional Experience
  • Necessary: Experience within manufacturing industries
  • Desirable: N / A
• Languages: Fluency in English and Italian