Process Manufacturing Expert (Sostituzione

Thermo Fisher Scientific; Monza; In loco; EUR 45.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading scientific services company in Monza is seeking a Manufacturing Process Expert to support problem-solving and continuous improvement initiatives. This role involves conducting advanced root cause analyses, managing deviations, and ensuring compliance with GMP standards. The ideal candidate will possess a degree in Chemistry or related fields and experience in Quality Assurance operations. Strong interpersonal and communication skills, alongside fluency in English and Italian, are essential for success in this fast-paced environment.

Competenze

• Experience in Quality Assurance focusing on deviation management.
• Ability to operate in a fast-paced environment with multiple priorities.
• Fluency in English and Italian.

Mansioni

• Service as advanced root cause analysis expert.
• Facilitate and perform advanced root cause analyses.
• Support Manufacturing in implementing Corrective and Preventive Actions.

Conoscenze

Root Cause Analysis

GMP Knowledge

Interpersonal Skills

Communication Skills

Planning and Organization

Technical Competencies

Formazione

Degree in Chemistry / CTF / Biological Sciences

Strumenti

TapRoot

Descrizione del lavoro

MAIN SCOPE OF THE POSITION / RESPONSIBILITIES

The Manufacturing Process Expert will serve as an advanced root cause analysis expert supporting a cross-functional team focused on problem-solving and continuous improvement at the site. The investigation team is a key part of the Technical Unit organization, dedicated to driving quality excellence, error prevention, deviations, continuous improvement, and effective problem-solving. The Manufacturing Process Expert is responsible for facilitating and performing advanced root cause analyses to resolve complex technical problems.

• ASSIGNMENTS, SPECIFIC / PRIMARY ACTIVITIES
• Investigations
• Management of deviations in collaboration with cross-functional teams
• Investigation plan definition
• Guide and execute Root Cause Analysis for deviation events and define CAPA with cross-functional teams
• Execute technical analysis inside and outside the Technical Unit
• Lead cross-functional investigation teams within and outside the Technical Unit
• Utilize manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and promote continuous process improvements
• Technical process knowledge / Production
• Support Manufacturing in implementing Corrective and Preventive Actions (CAPA) in collaboration with Quality Specialists
• Proactively identify and mitigate risks
• Share lessons learned during Technical Unit huddles
• Audit
• Use manufacturing process knowledge and investigation skills during client and regulatory audits related to deviations
• Methodology / KPI
• Contribute to achieving "zero past due" objectives in Quality (CAPA, Deviations) within scope, as well as RFT (Right First Time) and OTIF (On-Time In Full) objectives for document submission and lot release
• RELATIONS
• Internal (examples include)
• All functions and seniority levels
• Direct report to Qop Manufacturing Supervisor
• Collaborate with the Technical Unit's Quality Specialist
• External (examples include)
• 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, focusing on deviation management and GMP manufacturing support. Excellent knowledge of GMP and international regulations

Technical competencies

Necessary

Ability to operate in a fast-paced, dynamic environment with multiple priorities

Strong interpersonal and communication skills, both written and oral

Thorough knowledge of cGMP

Ability to write, handle, and review GMP documentation (Deviations, CAPAs) and understand key quality indicators

Knowledge of injectable sterile process manufacturing

Desirable

Solid understanding of root cause analysis tools, preferably TapRoot

Strong planning, organization, and multitasking skills

Professional experience

Necessary (examples)

Experience in manufacturing industries

Fluency in English and Italian