Process Manufacturing Expert

8 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**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.

**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
- Lead 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 Knowldgment/Production**
- 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 (alcuni esempi)**
- All functions and seniority levels
- Direct report of Qop Manufacturing Supervisor
- Collaboration with Quality Specialist of the TU

**External (alcuni esempi qui sotto)**
- 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.
- Thorough knowledge of cGMP.
- 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.

**Professional Experience**:
Necessary (esempi)
- Experience within manufacturing industries
- Fluency in English and Italian

  • Process Manufacturing Expert

    2 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **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...

  • Process Manufacturing Expert

    3 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES**: **The Manufacturing Process Expert will serve as a sophisticated 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...

  • Process Manufacturing Expert

    2 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **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...

  • Process Manufacturing Expert

    4 settimane fa

    Monza, Italia Mygwork A tempo pieno

    This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES: The Manufacturing Process Expert...

  • Process Manufacturing Expert

    2 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **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...

  • Manufacturing Process Expert – Quality And Deviation

    4 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeCompany OverviewThermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions that enable our customers to make the world healthier, cleaner, and safer. With a strong commitment to...

  • Manufacturing Process Expert

    3 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionThermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions that enable our customers to make the world healthier, cleaner, and safer. With a strong commitment to...

  • Manufacturing Process Expert – Quality And Deviation

    4 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeCompany OverviewThermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions that enable our customers to make the world healthier, cleaner, and safer.With a strong commitment to...

  • Manufacturing Process Expert

    4 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Thermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions that enable our customers to make the world healthier, cleaner, and safer. With a strong commitment to...

  • Manufacturing Process Expert

    4 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Company Overview Thermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions that enable our customers to make the world healthier, cleaner, and safer. With a strong...

  • Manufacturing Process Expert

    2 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeThermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions that enable our customers to make the world healthier, cleaner, and safer. With a strong commitment to excellence,...

  • Manufacturing Process Expert – Quality and Deviation

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Deviation management Facilitate and perform advanced root cause analysis to solve complicated technical problems Collaborate with a cross-functional team to drive problem-solving and continuous improvement initiatives Conduct thorough investigations and provide expert recommendations to prevent errors and deviations Determine the underlying causes of...

  • Manufacturing Process Improvement Specialist

    2 settimane fa

    Monza, Lombardia, Italia Mygwork A tempo pieno

    Mygwork, an inclusive employer and a member of the largest global LGBTQ+ business community, seeks a skilled Manufacturing Process Improvement Specialist to join their team at Thermo Fisher Scientific.About MygworkWe are an inclusive employer committed to creating a diverse and welcoming work environment. As a member of myGwork, we offer a platform for the...

  • Manufacturing Process Quality Assurance Specialist

    3 settimane fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Company OverviewThermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions to make the world healthier, cleaner, and safer.SalaryWe offer a competitive salary of approximately $80,000 - $110,000 per year based on location and experience.Job DescriptionWe are seeking a skilled Manufacturing Process Expert with...

  • Manufacturing Process Specialist

    3 settimane fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Company Overview:Thermo Fisher Scientific Inc. is a world leader in serving science with annual revenue exceeding $40 billion. Our mission is to enable our customers to make the world healthier, cleaner, and safer.Job Description:We are seeking a highly motivated Manufacturing Process Specialist for the PDS team in Monza, Italy. The successful candidate will...

  • Regulatory Compliance Expert

    2 settimane fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About the RoleWe are seeking a highly skilled Regulatory Compliance Expert to join our team at Thermo Fisher Scientific. This is an exciting opportunity to work in a newly-established mRNA GMP manufacturing facility in Monza, Italy.ResponsibilitiesAdvise on licensing strategies for innovative mRNA products and partner with the Qualified Person to ensure...

  • Manufacturing Process

    3 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences...

  • Manufacturing Process

    2 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex...

  • Manufacturing Process

    4 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex...

  • Manufacturing Process

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    : As Process Scientist you will craft the manufacturing process chart in accordance with the product quality target product profile, product knowledge and development data as well as write clear and professional protocol to support timely project completion. Craft and develop robust and scalable manufacturing process. Support scale-up of lab-scale...