Process Manufacturing 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.

ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES:

1. Investigations:
   Management of deviations, in collaboration 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
   Lead cross-functional investigation team inside and outside the Technical Unit
   Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
2. Technical process Knowledge/Production:
   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
3. Audit:
   Utilizes manufacturing process knowledge and investigation skills during client and Regulatory audit for the deviation assigned
4. 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
Direct report of Qop Manufacturing Supervisor
Collaboration with Quality Specialist of the TU

External:
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 simultaneously.
Strong interpersonal and communication skills; written and oral.
Thorough knowledge of cGMP.
Must be skilled in meetings and interviews to elicit 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.

Professional Experience:
Necessary:
Experience within manufacturing industries
Desirable:
N/A

Languages:
Fluency in English and Italian