Manager Engineering
Resume:
MICHAEL P. KOSTURKO
BELLEVILLE, NEW JERSEY 07109
OBJECTIVE: To obtain a position that will best utilize my extensive
knowledge of the pharmaceutical and consumer healthcare
industries, as well as my prior employment and educational
experience.
EDUCATION: Bloomfield College, Bloomfield, New Jersey
B.S., Business Administration - Computer Information Systems,
graduated
Cum laude, 1999
Bloomfield College, Bloomfield, New Jersey
Certified in computer programming, August 1993
Concentrated in computer programming for business
applications and
obtained knowledge of system analysis and design.
Computer Learning Center, Paramus, New Jersey
Certified in Computer Operations, June 1984
J & J Computing Incorporated, Suffern, New York
Trained in the use of QuarkXpress, Adobe Illustrator, Photoshop and
Freehand
Member of Delta Mu Delta and Alpha Chi honor societies
Member of the New Jersey Packaging Executives Club (NJPEC)
EMPLOYMENT:
February 2007 Novartis Consumer Health, Inc., Parsippany, New Jersey
to October 2009: Manager of Package Engineering
- Responsible for all operational packaging activities
related to third party contracted
products.
- Evaluated new & existing packaging designs for third party
contracted
products.
- Initiated and managed projects to develop the materials and
packages for third party contracted products to maintain and
improve product quality, cost and productivity.
- Collaborated with the Global Packaging Innovation &
Engineering team to design, evaluate and select new materials
and packages for third party contracted products.
- Managed two Packaging Engineers.
- Authored, reviewed and approved packaging waivers and rework
procedures.
- Interfaced with Creative Services to develop all artwork
templates and obtained copy approvals for printed components.
- Prepared IQ, OQ, PQ and packaging validation protocols and
conducted validation at third party manufacturing facilities.
- Developed and distributed third party master packaging bills
of material and package component specifications which
controlled the contractors manufacturing processes.
- Created and assigned code numbers for packaging components,
bulk code numbers, waivers, reworks, validation protocols and
validation reports.
- Created pallet patterns for all third party contracted
products.
- Developed SOP's as they related to the Package Engineering
job function for third party contracted products.
- Coordinated testing (Child Resistant Compliance, Distribution
Handling, Equipment Qualification) for third party contracted
products.
- Project lead assigned to identify e-pedigree solutions for
all third party Rx packaging.
April 2005 to
February 2007: Pfizer Consumer Healthcare, Peapack, New Jersey
Manager/Team Leader - Package Design and Development
- Managed all packaging activities for new product launches and
promotions.
- Worked closely with Marketing, Sales, Regulatory Affairs, as
well as with global manufacturing departments including
Supply Chain, Quality, Contract Manufacturing and Pfizer
manufacturing sites to ensure all package engineering related
functions were completed on time.
- Worked closely with Package Design and Development (PDD)
colleagues to complete accurate artwork, specifications and
bills of material.
- Worked closely with Packaging Engineering Services (PES) and
the manufacturing sites to ensure smooth introduction of new
packaging and to support site initiatives with cost
improvements and product transfers.
- Closely interacted with Global Package Technology and Testing
(GPT&T) on all package testing protocols.
October 2002
to January 2005: Hoffmann-La Roche, Inc., Nutley, New Jersey
Senior Package Developer
- Designed and developed packages for use in the production packaging
departments
located at the U.S., Switzerland, Spain, Mexico and Germany
facilities as well as contractor packaging sites located in
Puerto Rico and Canada.
- Performed transit testing for all new package designs.
- Coordinated both child resistant and USP testing.
- Developed all component drawings using AutoCad software.
- Developed inner package and shipper quantities and designs as
well as pallet patterns.
- Determined packaging configurations and materials for use in
stability protocols.
- Issued engineering change notifications for all packaging
changes.
- Issued wholesaler fact sheets and created labeling and
component purchasing specifications.
- Created bar coded intermediate and shipper labels.
- Created bills of material and component specifications for
use in the Purchasing and Production departments
October 1995
to October 2002: Abbott Laboratories, Inc. (formerly Knoll Pharmaceutical
Company),
Whippany, New Jersey
Manager of Finishing Operations and Package Design and Development
- Designed, updated and maintained all printed drug labels,
blister cards, cartons, print mats, package inserts and
various marketing layouts in accordance with cGMP's and FDA
guidelines for all currently manufactured products as well as
new product launches, utilizing QuarkXpress, Adobe
Illustrator, Photoshop, Freehand and MacBarcoda software on a
Macintosh computer system for all former Knoll sites
worldwide.
- Developed cost effective packaging designs for use on
Klockner thermoforming machinery and CAM, Jones and IWKA
cartoning equipment.
- Aided in the composition of all labeling component text in
multiple language formats for use at all sites worldwide,
including: U.S., Germany, Brazil, Canada and Australia.
- Generated, proofread and circulated all artwork, blueprints
and color keys to Regulatory Affairs, FDA, Marketing, Quality
Assurance, Quality Control and Legal departments for
approvals.
- Created and maintained all labeling component purchasing
specifications.
- Maintained electronic labeling artwork files and revision
history data.
- Maintained Macintosh computer equipment and upgraded system
software when new software revisions and technologies were
available.
- Interacted daily with the Planning and Purchasing
departments, printing suppliers and contract packaging
facilities to ensure that all labeling components were
printed to specification and were delivered on a timely basis
according to strict production schedules and product launch
deadlines.
- Managed a staff consisting of packaging supervisors,
production line operators, group leaders, packaging
mechanics, material handlers, packaging engineers and one
graphic specialist.
- Scheduled the daily packaging department activities on the
production floor with the aid of the packaging supervisors
and planning department.
- Managed the Label Control Room staff and monitored and
maintained all labeling component inventories.
- Supported budgeting and capital planning by monitoring direct
controllable costs, overtime and supporting various capital
projects. Enforced site safety initiatives for the Finishing
department, via training and departmental audits.
- Authored and maintained the standard operating procedures for
the Label Control and Finishing Operations departments and
facilitated training classes for both departments.
October 1994
to October 1995: Almedica Corporation, Waldwick, New Jersey
Clinical Packaging Label Control Supervisor
Responsibilities included the daily supervision of the Label Control
staff and the
review and analysis of investigational drug clinical trials.
The designing and printing of computer generated prescription
labels and the generation of patient randomizations and package
design reports.
March 1987
to September
1994: Hoffmann-La Roche, Inc., Nutley, New Jersey
Pharmaceutical Labeling Technician for Clinical Packaging
Responsibilities included the review and analysis of investigational drug
clinical trials. The designing and printing of prescription labels and the
generation of patient randomizations and packaging design reports.
Additional responsibilities included the writing of standard operating
procedures for clinical trial labeling and inspection.
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