Manufacturing Process Expert

ThermoFisher Scientific; Monza; In loco; EUR 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Manufacturing Process Expert to join our Monza site, where you will serve as an advanced root cause analysis expert within a cross-functional team focused on problem-solving and continuous improvement. You will drive quality excellence and support CAPA, deviations, and audits in a GMP environment.

The role requires strong analytical skills, English/Italian fluency, and experience with TrackWise and regulatory processes.

Competenze

• Degree in Chemistry/CTF/Biological Sciences or similar field.
• Experience in QA operations, deviation management, GMP manufacturing.
• Knowledge of GMP and national/international regulations.
• Fluency in English and Italian.

Mansioni

• Investigations: lead deviation management and cross-functional collaboration.
• Define investigation plans and guide Root Cause Analysis for deviations.
• Coordinate CAPA with cross-functional teams and support audits.
• Apply technical analysis to identify manufacturing issues and drive improvements.
• Share lessons learned during Technical Unit huddles and maintain KPI alignment.

Conoscenze

Root Cause Analysis

cGMP

TrackWise

CAPA

Deviations

Quality Assurance

Documentation

Regulatory Audit

Bilingual EN/IT

Formazione

Chemistry/CTF/Bio Sci degree

Strumenti

TrackWise

Descrizione del lavoro

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

• 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.