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Process Manufacturing Expert

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Thermo Fisher Scientific

1mo ago

  • Job
    Full-time
    Senior Level
  • Engineering
  • Milan

AI generated summary

  • You need a degree in Chemistry or related field, GMP knowledge, QA experience, strong communication skills, proficiency in documentation, and fluency in English and Italian.
  • You will lead root cause analyses, manage deviations, drive continuous improvement, implement CAPA, and facilitate cross-functional investigations to ensure quality excellence and mitigate risks.

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:
  • Ability to function in a fast paced, multifaceted environment with multiple priorities simultaneously.
  • Strong interpersonal and communications skills; written and oral.
  • Thorough 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 helpful.
  • 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
  • Experience within manufacturing industries
  • Fluency in English and Italian

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 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.
  • Management of deviations, in teamworks with cross functional team
  • Investigation plan definition
  • Lead and/or complete the Root Cause Analysis for deviation events and guide the definition of CAPA with a cross-functional team
  • Implement technical analysis within and outside the Technical Unit
  • Lead cross functional investigation team inside and outside the Technical Unit
  • Applies knowledge of manufacturing processes and investigation skills to identify and resolve manufacturing issues, while driving continuous improvement in process operations.
  • 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
  • Applies manufacturing process knowledge and investigation skills when conducting client and Regulatory audits for assigned deviations.
  • Give 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.

FAQs

What is the work schedule for the Process Manufacturing Expert position?

The work schedule is standard Monday through Friday.

In what environmental conditions does the Process Manufacturing Expert work?

The role is primarily office-based.

What are the main responsibilities of the Process Manufacturing Expert?

The main responsibilities include leading root cause analysis for deviations, facilitating investigations, and collaborating with cross-functional teams to drive quality excellence and continuous improvement.

What is the importance of the cross-functional investigation team in this role?

The cross-functional investigation team is crucial for problem-solving, implementing corrective and preventive actions (CAPA), and driving continuous improvement initiatives at the site.

What qualifications are required for this position?

A degree in Chemistry, CTF, Biological Sciences, or a related field is required.

Is experience in Quality Assurance Operations necessary for this job?

Yes, experience in Quality Assurance Operations with a focus on deviation management and GMP manufacturing is desirable.

What technical competencies are necessary for the Process Manufacturing Expert?

The role requires strong interpersonal and communication skills, thorough knowledge of cGMP, and proficiency in using personal computers and related software applications.

What specific knowledge is preferred for the Manufacturing Process Expert role?

A solid understanding of root cause analysis tools, particularly TapRoot, and knowledge of injectable sterile process manufacturing is preferred.

Is bilingual proficiency required for this position?

Yes, fluency in English and Italian is required.

What is expected regarding managing deviations as part of the job?

The Process Manufacturing Expert is responsible for managing deviations, leading investigations, and developing corrective and preventive actions in collaboration with the Quality Specialist.

Will the Process Manufacturing Expert conduct audits?

Yes, the role involves conducting client and regulatory audits for assigned deviations using manufacturing process knowledge and investigation skills.

How does this role contribute to quality objectives?

The Process Manufacturing Expert plays a key role in achieving "zero past due" objectives in Quality (CAPA, Deviations) and supports Right First Time (RFT) and On-Time In Full (OTIF) objectives.

What interpersonal skills are necessary for the role?

Strong interpersonal and communication skills, both written and oral, are necessary for effectively engaging with various functions and stakeholders.

What is a major responsibility during investigations?

A major responsibility is to lead and complete root cause analysis for deviation events and guiding the definition of CAPA with the cross-functional team.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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 analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.