Jim Fleury
Senior Quality Engineer II at Takeda at Takeda | Framingham, Massachusetts, United States
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Jim Fleury is a Senior Quality Engineer II at Takeda, where he leverages his extensive expertise in process engineering and automation to enhance the quality assurance and validation processes within the biopharmaceutical sector. With a strong focus on Quality Assurance Validation (QAV) and Computer System Validation (CSV), Jim plays a pivotal role in ensuring that Takeda’s bioprocessing operations meet stringent regulatory standards while maintaining the highest levels of product quality. His proficiency in bioreactor design and startup has been instrumental in driving key projects that optimize production efficiency and scalability, particularly in aseptic processing environments.
Currently, Jim is spearheading several critical initiatives aimed at quality remediation and technology transfer, ensuring that new processes and systems are seamlessly integrated into existing frameworks. His project management skills enable him to navigate complex change control processes, ensuring that all modifications are thoroughly evaluated and documented to mitigate risks. Jim's expertise in Corrective and Preventive Actions (CAPA) further enhances his ability to identify potential quality issues and implement effective solutions, reinforcing Takeda's commitment to excellence in the pharmaceutical industry.
In addition to his technical skills, Jim is a proactive collaborator, working closely with cross-functional teams to foster a culture of continuous improvement. His dedication to advancing biopharmaceutical technologies not only enhances operational efficiencies but also contributes to the overall mission of delivering life-saving therapies to patients worldwide. Through his innovative approach and unwavering commitment to quality, Jim Fleury exemplifies the core values of Takeda and the biopharmaceutical industry at large.
Senior Quality Engineer II at Takeda at Takeda in January 2021 to Present
Sr QA specialist at Shire in June 2018 to January 2021
QA Specialist at Shire in May 2018 to June 2018
Principle Quality Engineer at Genzyme in May 2011 to February 2018
Sr Engineer at Genzyme in December 1987 to May 2011
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Framingham State University, BS, July 1983 to July 1986
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Validation
GMP
Process Engineering
Process Equipment
Process Automation
Remediation
Project Management
Change Control
Biopharmaceuticals
Pharmaceutical Industry
21 CFR Part 11
CAPA
Biotechnology
Technology Transfer
Aseptic Processing
FDA
Quality System
SOP
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Discover more about TakedaWhat is Jim Fleury email address?
Email Jim Fleury at [email protected] and [email protected]. This email is the most updated Jim Fleury's email found in 2026.
What is Jim Fleury phone number?
Jim Fleury phone number is 5085612619 and 3056817116.
How to contact Jim Fleury?
To contact Jim Fleury send an email to [email protected] or [email protected]. If you want to call Jim Fleury try calling on 5085612619 and 3056817116. (updated on September 04, 2024)
What company does Jim Fleury work for?
Jim Fleury works for Takeda
What is Jim Fleury's role at Takeda?
Jim Fleury is Senior Quality Engineer II at Takeda
What industry does Jim Fleury work in?
Jim Fleury works in the Biotechnology industry.
Jim Fleury Email Addresses
Jim Fleury Phone Numbers
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