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 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
   • 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 communications skills; written and oral.
• Thorough 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.

Professional Experience:

Necessary:
• Experience within manufacturing industries

Desirable:
• N/A

Languages:

• Fluency in English and Italian