PAVEL PAUL ZAGULA

**** ***** *** *****, ****, North Carolina 27539 (C) 919-***-**** Email: acfpit@r.postjobfree.com

**** ***** *** *****, ****, North Carolina 27539 (C) 919-***-****

acfpit@r.postjobfree.com

Professional Summary

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Highly skilled and talented Engineering Project Manager with a broad range of expertise in Designing, R&D,

Manufacturing and Production Processing for Pharmaceutical and Medical Devices field, gained in the over 20 years

of “hands on” Engineering career. Demonstrates an excellent knowledge of Project Management of small to medium

size projects, Validation & Quality Assurance Principles and Medical Affairs. Possesses a proven track record of

Continuous Process Improvement with use of Lean Six Sigma Methodology in accordance with cGMP and Medical

Regulatory Standards. As a Project Manager initiated and successfully delivered several projects with over $10 million

budget combined. Experienced, charismatic and valued Manager and Team Leader with a set of excellent collaborative

skills.

Skills

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● Project Manager Certification from Villanova University.

● Six Sigma Green Belt Certification by Aveta Institute (Black Belt in progress).

● Clinical Trial Project Management Certification (in progress).

● Throughout Exposure and Knowledge of Aseptic Processes (Mixing, Bulking, Filtration, Filling).

● Participation in Clinical Research including a Human Cadaver Study.

● Broad knowledge of Validation and Medical Regulatory, HVAC/cGMP, FDA 510(k) and ISO 13485

for Medical Devices Class III.

● Cognex Vision System Advanced Certification.

● Product design and review with Solid Works and Auto CAD.

● Lean Manufacturing, DFM and DFA and GMP Standards and Principles.

● Performance optimization, and Failure Analyses: FEA and FMEA.

● Expertise in troubleshooting and creative problem solving-CAPA, RCA, NIR.

● Ability of creating Manufacturing Directions (MDs) and Standard Operating Procedures (SOP) in

accordance of Regulatory and cGM for pharmaceutical/medical devices products.

● Working knowledge of interpreting and revising P&IDs with AUTOCAD.

● Broad knowledge of specific HVAC aspects and requirements for Aseptic Processing.

● Highly skilled in Project Manager software, Visio, Excel, MS Office.

● Proven skill of Project Management and Leadership and Mentoring.

● Strong social and communication skills with Stakeholders

.● Proficient in four Foreign Languages (Norwegian, Italian, German and Polish).

Work history

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SENIOR ENGINEERING PROJECT MANAGER 09/2013-present

Biomerieux, 100 Rodolphe St. Durham, NC 27712, USA

• Plan, develop, initiate Stage Gate, manage and implement project plan to meet business needs and make

decisions to carry out the plan.

• Initiates and leads Continuous Improvements to equipment and processes of aseptic mixing, bulking,

filtration and filling of bacT/ALERT products.

• Provides technical expertise and support to Manufacturing and Quality Control processes in R&D and

Manufacturing of in Vitro diagnostics.

• Maintain all project management documentation in appropriate form files and updates the file accordingly to

the Project evolution.

• Initiates and completes Process and Document Change Controls supporting Manufacturing and Facility.

• Creates and revises Manufacturing Directions (MDs), Standard Operating Procedures (SOPs) and P&IDs.

• Leads manufacturing projects within current QSR & ISO guidelines while maintaining compliance to

Regulatory requirements for pharmaceutical industry.

• A member of cross functional Lean Six Sigma Board, which contributed to multi million dollars “scarp”

savings over years.

• Successfully re-initiated, and re- integrated and delivered several of Continuous Improvement Projects, which

failed in the past.

MECHANICAL ENGINEER 03/2009 to 09/2012

Transenterix – 635 Davis Drive, Suite 300, Durham, NC 27713, USA

• Played a key role in designing and prototyping medical devices that help reduce the invasiveness of surgery for

patients while enhancing the capabilities of surgeons that resulted in launching a break through surgical SPIDER

SYSTEM.

• Assisted in Clinical Research, including Porcine, Poultry and Human Cadaver.

• Managed moderate complexity Projects contributing to FDA510(K) Product Approval.

• Promoted to Engineering Lead of Prototyping Department contained of 6-8 employees within 4 years. Started as

Senior Model Maker at the company, one of the first hired employees who contributed to successful transition of

the start- up company into a public owned, leading developer and manufacturer of Endoscopic intuitive surgical

devices.

PROCESS ENGINEER 07/2004 to 02/2009

Madern USA – 1010 Burma Street, Apex, NC 27526, USA

• Managing the manufacturing process flow projects in accordance of cGMP Standards.

• Developed and implemented Manufacturing Directions and Standard Operating Procedures.

• Participated in designing of new products with accordance of DFM/DMA principles.

• Created documentation, blueprints, work instruction, Standard Operation Procedures.

• Leading Failure Analyses and Continues Process Improvement Teams.

MECHANICAL ENGINEER 03/2002 to 06/2004

Tomsed Corporation – 420 McKinney Parkway, Lillington, NC 27546, USA

• Played key role in designing and manufacturing of turnstiles, security gates and barriers with use of Auto CAD.

• Managed Process and Facility Improvements projects.

• Administrated projects into production within cGMP Standards.

• Supervised daily production department of 30 employees during in the absence of the department manager.

• Reduced amount of “waste” by implementing Six Sigma Methodology.

R&D PROJECT ENGINEER 01/2001 to 02/2002

Knoll Pharmaceuticals – 3000 Continental Dr. North, Mt. Olive, NJ 07828, USA

• Participated in the development of the incubator for a new molecular test to monitor for recurrent bladder cancer.

The technology patent was acquired by Abbott Technologies and released under the Vysis UroVysion trademark.

PROJECT ENGINEER 08/1998 to 12/2000

Pegaspol – ul. Srebrna 160, Katowice, POLAND

• Researched product brief to develop market fundamental understanding of customer applications for variety of

medical wheelchairs. Deeply involved in developing manufacturing and assembling process risk analysis in

accordance to medical Regulatory, including ISO 9001, etc.

• Member of the design team who pioneered the concept of 3 wheels wheelchair

• Talent of The Year Employee Award in 2000

R&D ENGINEER 04/1996 to 08/1998

Hellma Italia S.p.A – Via Gioaccino Murat 84, Milano, ITALY

• Participated in research of optical components for broad range of Spectroscopy instruments (scanning devices,

optical sensors, etc.)

• Designed 3D models of complex optical assemble housing, like Linear Opthomalic Spectroscope

• Generated ideas and solutions for use of fibber optics diode array system for breast cancer detection.

PROCESS ENGINEER 01/1995 to 03/1996

Moto Guzzi S.p.A ( formerly G.B.M. S.p.A) – Via E.V. Parodi 57, Mondello del Lario, ITALY

• Developed manufacturing process for production of high tolerance parts, like pistons (within 0.01 mm).

• Oversaw the transfer of projects from R&D to the production process.

• Interpreted drawing mark ups and implemented drawing revisions provided by engineers on the shop floor.

• Assisted technical support department and QA in troubleshooting product returns and after-sales support.

Education

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Masters of Science (MSME) BIO MECHANICAL ENGINEERING University of Science and Technology

(Akademia Gorniczo Hutnicza) - Krakow, POLAND (accredited University) 2011

Bachelor of Science (BSME): MECHANICAL ENGINEERING University of Applied Science Oslo

and Akershus (Hogskolen I Oslo og Akershus) - Oslo, NORWAY (accredited University) 1994

ADVANCED PROJECT MANAGEMENT PROFESSIONAL Villanova University, USA 2012

LEAN SIX SIGMA GREEN BELT CERITIFICATION Aveta Business Management Institute 2013

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