Work Schedule

Standard (Mon-Fri)Environmental Conditions

Office

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
- 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

📌 Manufacturing Process Expert (Monza)
🏢 Thermo Fisher Scientific
📍 Monza