Manufacturing Process Expert

Work Schedule

Environmental Conditions

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