Steve Sanders' Resume

1. STEVEN P. SANDERS
7648 Ashmont Circle
Tamarac, Florida 33321
CELL: 609-647-3742 E-MAIL: spsndrs@gmail.com
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SUMMARY
 Senior Packaging, Project Engineering, Quality Engineering, and Project Manager with significant
experience in the Pharmaceutical, Biotechnology, Medical Device, Cosmetic, and Diagnostic
industries.
 Handled numerous complete Packaging projects from concept to completion.
 Extensive hands on packaging development and equipment design experience with liquids, creams,
ointments, blisters, secondary packaging, etc.
 Launched new packaging lines, including startup, commissioning, and Validation.
 Involved with various packaging equipment including blister machines, bottlers, washers, fillers,
cappers, labelers, sterilizers, cartoners, case packers, robots, vision systems, wrappers, palletizers,
and customized packaging machinery.
 Integrated multiple packaging machines into full packaging lines, creating interactive communication
handshakes between machines from various suppliers.
 Performed packaging validations. Wrote and executed FAT, IQ/OQ, and PQ protocols and test
reports.
 Excellent team player and project leader. Work and communicate well with Management, vendors,
and operational personnel.
 Proven track record of successfully meeting goals within budgets and on time.
EXPERIENCE
DEPUY ORTHOPAEDICS (Johnson & Johnson)/ACRO SERVICES, Raynham, MA Oct 2014 – Present
Quality Engineer III
Assigned by Acro Services as a Consultant to DePuy Orthopaedics, a division of Johnson & Johnson, to
develop all relevant protocols and lead the efforts to validate equipment, software, and systems required to add
2D barcodes to all of the company’s medical implant devices. Projects involved adding and validating
automated systems for engraving and/or laser etching 2D barcodes and OCR human readable codes onto
plastic and metallic medical Class 2 and Class 3 implant devices, as well as automated verification of these
codes via barcode scanners and vision systems. Validations resulted in FDA submissions and the review of all
documents associated with these projects, and ultimately gaining FDA approval to fully implement. Developed
and authored complex validation (Process Verification and Process Qualification) protocols and risk
assessment (PFMEA) documents, and authored summary reports after participating in validation efforts.
Organized and provided full document packages for FDA submissions.
ASTRA ZENECA/OXFORD GLOBAL RESOURCES, Westborough, MA May 2014 – Aug 2014
Project Engineer
Assigned by Oxford Global Resources as a Consultant to Astra Zeneca to help manage, coordinate, and
complete their major project of installing and validating two new automated packaging lines with multiple
equipment to replace older outdated packaging lines for the production of Pulmicort Respules.
KRAFT FOODS/ EQUITY PACKAGING, INC. Tarrytown, NY April 2013 – Nov 2013
Senior Packaging Equipment Engineer
Assigned by Equity Packaging, Inc. as a Consultant to Kraft Foods for Kraft’s Packaging Equipment
Development group. Researching and developing packaging equipment and methods required to produce a
new coffee product in a new container and suggesting Proof of Principle concepts, costs, and timing.

2. INDEPENDENT PACKAGING CONSULTING March 2008 – April 2013
Worked on various packaging equipment and component projects, and as a Commissioning/Validation
Specialist for various company clients such as Teva Animal Health, Bayer Animal Health, and Mylan Labs at
the clients’ manufacturing plants
SYSTECH INTERNATIONAL, Cranbury, NJ March 2007 – Feb 2008
Project Manager
Managed all aspects of numerous projects simultaneously in support of sales, installation, and implementation
of company products and solutions, involving Vision, Serialized Product Tracking, and RFID. Primary post-sale
contact with company customers and OEM’s; including Wyeth Labs, Merck, Genzyme, Roche Diagnostics,
Baxter Healthcare, Hospira, TEVA Pharmaceuticals, Boehringer-Ingelheim, Watson Labs, Genentech, and
Lilly. Managed the entire scope and requirements of projects and served as liaison between team members
and the Customer.
 Acted as the main customer contact in the post-sales project delivery phase. Created and maintained
customer relationships; established and managed customer expectations for entire projects.
 Continually updated management about potential project slippage, budget over runs, and final product
quality issues.
 Executed NOC process to prevent project scope creep.
SCHERING-PLOUGH CORP., Kenilworth, NJ Oct. 2004 – Feb. 2007
Manager Mfg. Maintenance Compliance
Responsibilities included assisting in achieving compliance with programs used within the Kenilworth NJ
Manufacturing Maint. and Engineering Departments and the adherence to formal SOP’s and policies. Managed
the Technical Training Dept, which trained Packaging Mechanics in Procedures, Packaging Equipment Set-
Up/Change-Over and Maintenance requirements, and cGMP compliance. Managed the creation and approval
of Packaging Equipment and Packaging Line Manuals used in the training of Packaging Mechanics.
CARDINAL HEALTH, Philadelphia, PA 2002 – Oct. 2004
Contract Packager of Prescription Drugs and Biomedical Products.
Senior Project Engineer
Managed complex equipment/automation projects for client products. Prepared Factory and Site Acceptance
Test protocols, Installation/Operation and Production Qualification Protocols, in
accordance with FDA requirements and implemented. Supported ongoing production by troubleshooting.
 Purchased equipment for, and coordinated the successful installation of, two major automated integrated
packaging lines for the production of Amgen’s major injectable drug for the treatment of Arthritis, Enbrel.
Equipment included assembly machines, thermoformers, automated robotic feeders, cartoners, insert
feeders, labelers, case packers, checkweighers, and vision systems. Completed project consistent with
the launch date of the product.
 Purchased equipment for and coordinated the successful installation of major automated integrated
packaging lines for the production of Biogen’s major injectable drug for the treatment of Multiple Sclerosis,
Liquid Avonex. Equipment included assembly machines, thermoformers, automated robotic feeders,
cartoners, labelers, case packers, and vision systems. Completed project consistent with the launch date
of the product.
CARTER-WALLACE, INC., Cranbury, NJ 1983 - 2002
Manufacturer of Health Care products, Prescription Drugs, Clinical Diagnostic
products, and Animal Care products.
Director of Package Engineering (Corporate)
Managed and coordinated the Corporate Package Engineering/Development group,
interfacing with Divisional Production and Engineering Management (Domestic &
International) to develop, justify and implement new or revised primary and secondary
packages, products, and packaging lines. Managed the specification system and interacted
with Production, Marketing, R&D, Purchasing, Operations, and Q.C. Departments. Prepared and
submitted annual budgets and Capital Expenditures for all packaging equipment and component
projects. Resolved component quality issues, and proposed and completed Cost/Profit Improvement projects.
Reported to the Corporate Vice-President of Engineering. Among numerous highlights:

3.  Purchased and installed 6 new condom foiling and cartoning lines to fulfill the project requirements for a
new Trojan state-of-the-art condom plant in Colonial Heights, Virginia. Relocated all existing packaging
lines from old Trenton NJ plant simultaneously. Overall project savings for establishing this new plant was
$9 million dollars annually.
 Suggested, justified, and implemented new high speed automated valve/capping machine for Astelin, a
prescription nasal de-congestant, with projected annual savings of $200,000.
 Implemented the conversion of Arrid Solid Antiperspirants from round to oval containers, and engineered
packaging line and equipment changes required. Successfully moved production in-house from a contract
packager, with annual savings in excess of $500,000.
 Suggested and implemented the purchase of the highest speed, most automated
condom foiling machine in the world, with annual projected labor savings of
$150,000 and twice the output of previous machines.
 Suggested, justified, and implemented the conversion of Carter’s Little Pills packaging from an antiquated
vial format to a new blister card format, resulting in a $134,000 material and labor cost savings annually.
 Implemented the development and production of Arrid Gel, and assisted in the negotiations for initial
production with a contract packager to successfully launch the product nationally. Subsequently lead a
team to bring the production in-house, within budget and on time.
 Increased line speed for Arrid Aerosol production from 180 ppm to 360 ppm via line and equipment
upgrades.
 Overall Engineering project responsibility for closing antiquated manufacturing plants in California, Puerto
Rico, and New Jersey, and relocating production. Maintained seamless product availability and completed
projects on time and on budget.
EDUCATION & TRAINING
BA in English from Ithaca College, Ithaca, NY. Past Company representative to the IOPP (Institute of
Pharmaceutical Packaging Professionals) and the NJPEC (NJ Packaging Exec Club).
SKILLS
MS Project, MS Excel, MS Power Point, MS Outlook, MS Word