Engineer Manager

AMNON AMIT

*********@*****.*** • http://il.linkedin.com/pub/amnon-amit/6/108/5b4

**** ***** ****** **.,*******, TX 77096 Cell:832-***-****

MANUFACTURING PROCESS ENGINEER

Dynamic, results-driven Process Engineer with experience in leading and conducting product engineering and quality systems management within the pharmaceutical industry. Serves as a technical expert in support of manufacturing, maintaining comprehensive documentation, and evaluating process performance. Identifies process improvements to improve productivity, quality and cost effective delivery. Spearheads investigations, develops and implements Corrective Actions / Preventive Actions (CAPA) to reduce deviations. Oversees Change Control activities. Ensures regulatory compliance. Trains, coaches and manages highly proficient technical teams in the delivery of manufacturing engineering and operations excellence. Fluent in English and Hebrew.

AREAS OF EXPERTISE

Leadership • Pharmaceutical Manufacturing Process Engineering • Applied Process Expertise

Process Improvements • Deviation Investigations • Corrective Actions / Preventive Actions (CAPA)

Product Development • Change Control • Technical Training / Coaching • Regulatory Compliance

Process / Procedure Development • Team Management • Performance Monitoring / Improvement

PROFESSIONAL EXPERIENCE

TEVA PHARMACEUTICAL, Israel • 2008-2012

The world’s #1 Generic Pharmaceutical Company and the #13 largest Pharmaceutical Company.

Team Leader (2010-2012)

Led a 5-member Process Engineering team in achieving personal and unit goals. Recruited new engineers, establishing guidelines, setting targets and deadlines while ensuring their achievement. Prioritized operational schedules and participated in production solution development. Drove production deviation investigations of all 10 unit engineers.

Major Achievements:

• Decidedly improved the unit’s results concerning “on line” quality and regulator mandates, reducing delivery to 4 days in advance of the deadline with the creation of an effective work plan.

• Personally led and mentored a senior engineer’s success for $5M+ in strategic product rollouts, and his personal goal of securing the Plant Manager position.

• Empowered a young engineer’s growth by coaching him to work independently.

• Directed the team to a successful FDA audit in 2011.

• Supervised 5 engineers, 2 of which were former engineering peers.

Process Engineer (2008-2010)

Played a key role as a Project and Product Manager, leading chemical process transfers from lab to plant environments. Managed the full product lifecycle from initiation to client delivery while interacting with multiple internal and external resources. Developed Gantt scheduling, and delivered complex project results within a demanding and intensive work environment. Successfully passed FDA and other Health Ministry audits.

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AMNON AMIT • Page 2 • *********@*****.***

TEVA PHARMACEUTICAL (continued)

Major Achievements:

• Saved $199K+ annually through the implementation of a process improvement that shortened production time by reducing a single production stage.

• Delivered a challenging product’s supply quantity goals in 2009 and 2010 in collaboration with a special research and development (R&D) team.

• Grew the product’s manufacturing scale 4 times while implementing R&D experiments, resulting in a 20% RMC reduction and supply the $500K campaign to the customer on time.

• Managed the production of a problematic but strategic company product.

• Developed a successful product batch after 10 were rejected, and stabilized the product by identifying a solution to a 4-year old unsolved problem with the correct product filter adjustment in collaboration with a personally built 3-engineer team from different units.

ADDITIONAL TEVA PHARMACEUTICAL ROLE

Plant Engineer Assistant (2006-2008)

• Conducted production investigations.

• Produced reports and other documentation in line with good manufacturing practice (GMP) rules.

EDUCATION

Master of Business Administration - 2011

Ben Gurion University of the Negev, Beer Sheva, Israel

Bachelor of Science in Chemical Engineering - 2008

Ben Gurion University of the Negev, Beer Sheva, Israel

Polymers • Principles in Chemical Engineering • Separation and Distillation

Crystallization • Material and Energy Balances • Nano Structures in Soft Material

PROFESSIONAL DEVELOPMENT

Manager’s Development Course

Route Analysis Course

MILITARY SERVICE

First Lieutenant - Patrol Officer in Bridging Battalion (Reserved)

First Lieutenant - Engineering Corps (1998-1999)

Soldier in the Engineering Corps (1995-1998)

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