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