Project Manager, Manufacturing Engineering, Quality Assurance
Resume:
George H. Van Parys
PO Box ***** Bay Village, OH 44140
609-***-**** --- sh6g9o@r.postjobfree.com
PROFILE:
Various positions in Global Operations and Engineering and a Six Sigma Black Belt.
• Oversaw the design and Project Management of the largest installations of Robotics, Automation, and Quality Control in North America. Designed and implemented projects up to 250 MM (individually) in the US, Puerto Rico, and 10 foreign countries.
• Extensive experience in Pharmaceuticals, Medical Devices, Sterile Syringes, Plastic Injection and Blow molding, and Glass. Extensive packaging experience including thruput optimization and sterilization of Medical Devices. Aseptic filling and packaging systems for Parenteral drugs, including Aseptic clean rooms.
• System designs include the capability to read printing with a computer, the ability to robotically package with over 1200 variations, the ability to analyze if a container will fail years in the future, the processes for drugs like Advil.
• Consulted with the FDA to write sections of the cGMP’s including CFR211:122 on packaging line operations.
• Currently involved in engineering, design, and implementation for regulated Industries throughout the US inclusive of Pharmaceutical, Bio-Tech, Food and Beverage, Chemical Mfg., and Composite Mfg.
Core Competencies
Validation / Risk / FMEA Multi-Site Operations cGMP Compliance Manufacturing Engineering
Strategic Planning Project Management Quality Assurance Facilities Maintenance
Process Improvement ISO Requirements Lean Manufacturing Staff Motivational Training
Production Control Manufacturing Operations Systems Automation Change Management
EXPERIENCE:
Boehringer Ingelheim, Ben Venue Laboratories, Bedford,OH Through Aerotek Inc. 03/12 – Present
Ben Venue Laboratories is one of the largest generic injectable pharmaceutical companies in the United States Project Manager, Primary assignment; Packaging Equipment Rework, & Equipment Documentation.
Including but not limited to URS, FDS, CQ, COQ, IQ, OQ, PQ, Both write up and execution.
Vestas Wind Systems, Brighton, CO 04/10 – 03/12
The largest wind turbine manufacturer in the world.
Product Development, Senior Specialist, Robotics & Automation– Primary assignment, Blades Division
Vestas Wind Systems - Responsible for 9 plants world wide. Individual Projects to 15.0 MM
• Hands on major work on robotics and automation design covering various aspects of composite blade manufacturing, in worldwide facilities.
• Projects related to manufacturing operations on wind turbine blades to 178 feet long weighing 31,000 pounds.
• Designing of the largest physical size robotics installations in the world.
• Creating designs of totally automated quality and inspection functions of aspects of composite blade manufacturing.
M. Davis Inc. Wilmington, DE 05/08 – 04/09
MDavis is the premier Pharmaceutical & Industrial fabrication group, for companies like Baxter, AstraZeneca, & Wyeth. This group includes the Pharmaceutical / Food & Beverage / Cosmetic industries.
Project Management, Regulated Industries Group– Primary assignment, FDA / cGMP Operations
• Individual projects to 10.0 MM Held complete fiscal responsibility on all capital projects, including cost tracking and risk analysis.
• Hands on major work on process, batch, & packaging line redesigns, to improve material flow, product mixing and homogeneity of product to improve stability.
• Projects directly related to FDA / cGMP operations, to upgrade packaging line container handling, and packaging and product inspection equipment to achieve maximized production operation. (line speeds in excess of 1800 BPM)
• FMEA / DFMEA / PFMEA / CAPA analysis of potential failure modes within a system for classification by severity or determination of the effect of failures on the system, on both production and packaging operations.
• Major, White Paper analysis on production issues around cross-contamination & changeovers.
DMS Engineering, Mays Landing, NJ 06/01 – 04/08
Provider engineering services for the glass industry in India and the Pharma industry in Puerto Rico & the US Government.
Operations Manager / Lead Engineer – Primary assignment, DMS Engineering
Clients include Wyeth, Mova, Patheon, and Novapharm. Individual Projects to 250.0 MM
• Projects directly related to FDA warning letters, to upgrade process, packaging line container handling, and packaging and product inspection equipment to achieve renewed production operation.
• Hands on analysis work to determine Pharma process issues, such as batch contamination or DI water system contamination, to identify the issue, and install inspection equipment to detect future issues.
• Hands on major work on packaging line redesigns, to improve material flow and container handling, (line speeds in excess of 1200 BPM).
• Hands on engineering work on furnace design (process controls, process instrumentation, and electrical) as subcontractor for furnace design engineering companies.
• Remote glass furnace operations, including batch and furnace / forehearth operations. (Furnaces in India are controlled from the US)
• Performed extensive troubleshooting on SCADA, DCS, PLC, and PC controlled systems.
Kimble Kontes Glass, Division of Gerresheimer Vineland, NJ/Europe 11/98 – 06/01
Manager, Process / Engineering (Facilities in the US and Europe) Clients include GSK, TEVA, Lilly, and Schering. Individual Projects to 70 MM USD. US Sites FDA Regulated. Held complete fiscal responsibility on all capital projects, including cost tracking and risk analysis
• Supervision of 16 hourly and salary staff and Engineers.
• Operational responsibility for process, batch, and packaging operations in 2 major facilities in New Jersey & Illinois
• Major redesigns to companies various facilities glass furnaces, which are electrically & fuel heated.
• Hands on Design and installation of computerized manufacturing, process controls, process instrumentation, packaging systems and packaging lines.
• Hands on Design and installation of computerized inspection equipment, including major break throughs in technology of online vision systems.
• Complete fiscal responsibility on all capital projects, including cost tracking and risk analysis.
• Complete redesign of electrical wiring of the Chicago Heights Facility, including all operations.
• Extensive work in Process Hazard Analysis, as well as safety initiative integration into process and production operations.
Lawson Mardon Wheaton, Division of Aluswisse Millville, NJ 2/95 – 11/98
Manager, Process / Engineering (Facilities in the US and Europe) Clients include Alcon, Abbott, Berlex, and BMS. Individual Projects to 80 MM USD US Sites FDA Regulated. Held complete fiscal responsibility on all capital projects, including cost tracking and risk analysis.
• Supervision of 63 hourly and salary staff and Engineers.
• Operational responsibility for process, batch, and packaging operations in 3 major facilities in NJ and Missouri.
• Hands on Design and installation of computerized manufacturing, process control, process instrumentation, packaging systems and packaging lines.
• Hands on Design and installation of computerized inspection equipment, including major break troughs in technology of in-line vision systems.
• Hands on Design and installation of new concept in product conveying now termed “ultra-flow” conveying in the Pharma and glass industry.
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Whitehall Robins, Division of Wyeth (Facilities in the US and the Caribbean) 1986 - 1995
Manager, Systems and Security Engineering Individual Projects to 70 MM USD 1990 - 1995
Responsibilities include supervision of the following division wide functions:
• Supervision of 27 hourly and salary staff and Engineers.
• Operational responsibility for batch processing, manufacturing and packaging operations in 7 major facilities including, Hammonton New Jersey (2), Elkhart Indiana, Richmond Virginia (2), Guayama Puerto Rico (2).
• All Computer Aided Design systems.
• Hands on design and installation of computerized manufacturing, process control, packaging systems and packaging lines for liquid, solid dosage, and thermoform, as well as multi-component polymerization systems.
• Complete fiscal responsibility on all capital projects, including cost tracking and risk analysis.
• All electrical and energy projects including all EPA green light projects. Project scheduling and financial tracking for all engineering projects. Implementation of on-line TQM initiatives (hardware and software).
• Hands on design and installation of all HVAC control systems. Repair, maintenance and upgrading of all security systems. Engineering support for all new business development projects. Extensive work in Process Hazard Analysis, as well as safety initiative integration into process and production operations.
Senior Systems Engineer 1989 - 1990
Major accomplishments include:
• Installation of over 150 packaging line inspection stations in three manufacturing facilities. Installation of various packaging and manufacturing lines in all Whitehall Robins. Product reformulations on products like Reglan, Robitussin, and Triphasil.
• Facilities projects varying in value from three to five million dollars.
Systems Engineer 1988 - 1989
Major accomplishments include:
• Product reformulations & scale up’s on products like Preparation H, Today Contraceptive Sponge, and Premarin.
• Supervised the design, development and installation of a system of packaging line inspection stations. These stations detect missing or misplaced cotton, improper capping, improper labeling, incorrect coding of date/lot codes, incorrect cartons, incorrect cases, low filled bottles, missing or incorrect inserts and miss-glued carton flaps. Included in these systems are vision systems, bar code readers and various sensors. All stations are connected to a computer to collect counts and determine status. Many of these stations are the first of their kind to be developed.
Assistant Project Manager 1987 - 1988
Major accomplishments include:
• Formulation and scale up work on ketoprofen product. Developed second generation of Advil manufacturing system.
• Supervision of a 750-man work force for the construction of a major manufacturing plant in Puerto Rico. This plant was a 52 million dollar project which put 15 acres under roof and uses 15 megawatts of power. Responsible for all the design of the electrical systems, 20% of the mechanical systems and 10% of the civil engineering projects. Direct supervision of all aspects of building construction including installation of packaging and manufacturing equipment, interfacing with contractors, vendors and complete punch list and project sign-off responsibility.
Electrical/Instrumentation Supervisor 1987
Major accomplishments include:
• Supervised electricians, plant electronic and calibration technicians (12-18 people). Supervised the electrical and instrumentation installations for a 60,000 sq. ft manufacturing plant expansion. Supervised the electrical, instrumentation and HVAC installations for the construction of a new Research and Development building of 106,000 sq. ft. a 16 million dollar project.
Systems Engineering Technician 1986 - 1987
Major accomplishments include:
• Development of a computerized control system (hardware and software) for automated sugar coating of tablets, reducing coating time from thirty-nine (39) hours to eight (8) hours. (see products below)
• Developed manufacturing system for Advil product line, Advil, Trendar, and Co-Advil.
CAPP, INC. Philadelphia, PA 1982 - 1986
General Manager, Universal Machine Co. Division Projects to 5 MM USD
• Supervised 12 - 20 people of various disciplines
• Supervised Electronic Repair Group, Pneumatic and Instrumentation Repair Group, Panel and Control Systems Group, Field Service Group
Major accomplishments included:
• Designed and installed the control system for Prefinished Metals, Divisions of USX, for the longest paint line in the world. This line painted steel siding - longer than a mile and encompassed two stories.
• GE Power Turbine, Power Westinghouse Division on various manufacturing sub systems.
• Anchor Hocking on development of continuous on-line temperature measurement systems for Glass.
• Sikorsky Aircraft on the development of manufacturing the world’s first composite laminate helicopter rotor blades.
Publications & Other Accomplishments:
Published paper “Designing a CIM’s System Electrical Interface - Think Ahead” in Industrial Computing Magazine. March/April issue 1990.
Taught classes to corporate audiences in Total Quality Management, Modern Operations Management, Quality Assurance Testing / Documentation thru Automation.
Passed Industrial Electrical Contractor License in 1983 for Philadelphia as well as the State of Penna.
Prepared paper & gave presentation on “Designing the Best Electrical Interface for CIM’s
Systems” at the ISA International Conference in Philadelphia, Pa. on October 25, 1989.
Lectured on inspection equipment at the College of Engineering & Technology in San Juan, Puerto Rico, 1993.
Prepared paper & gave presentation “Inspection Systems Installation in a Pharmaceutical Environment” at the ISA International Conference in Chicago, IL, on September 1993.
SPECIALTY TRAINING:
Professionally Trained in: Total Quality Management, Organizational Management Culture Change, Lean Manufacturing Implementation, Six Sigma Black Belt, Cross Functional Team Communication, User/Supplier Bidirectional Communication, Quality Assurance Feedback Loop Communication, Team Building and Integration, Expert level knowledge on all Microsoft office and project software.
EDUCATION:
Bachelor of Science degree from Spring Garden College in Electrical Engineering
Bachelor of Science degree from Spring Garden College in Industrial Electrical Engineering & Industrial Engineering
George H. Van Parys
PO Box 40014
Bay Village, OH 44140
sh6g9o@r.postjobfree.com
APPENDIX A: SELECTION OF FDA & cGMP SPECIFIC PROJECTS:
McNeil division Johnson & Johnson, Lititz, PA.
Project design and installation work on automated product distribution system containing 10,000 gallons of 50% concentrate H2O2. Highly dangerous substance regulated by the Department of Homeland Security. Prior to this system chemical was transported by hand resulting in several serious injuries. Inclusive of required protocol write ups and commissioning execution.
AstraZeneca Pharmaceuticals Newark, DE
Project work on redesigning product packaging lines to reduce potential of cross contamination. This was in response to the company experiencing 7 recalls across 2 packaging lines. Inclusive of required protocol write ups (CAPA/Remediation/Investigation) and commissioning execution.
Baxter Pharmaceuticals, Cherry Hill, NJ
Project design and installation work on redesign of Heparin manufacturing system. This was in response to a 483 being issues to the company and the deaths of 81 people due to contamination of the product. Inclusive of required protocol write ups and commissioning execution.
Teva pharmaceuticals, North Wales, PA
Project work on redesign of DI & WFI water systems. This included updating the systems and increasing the size of the systems for use in other sections of the facility. Inclusive of required protocol write ups and commissioning execution.
Wyeth Pharmaceuticals, Pearl River, NY
Project work on packaging line reconfiguration to increase line thruput and reduce the risk of cross contamination. Work inclusive of 4 packaging lines, installation of new equipment and removal of excess machinery. Inclusive of required protocol write ups and commissioning execution.
Patheon / Mova, Caguas, PR
Project work in direct response to a 483 related to packaging line issues of under and over fill as well as line contamination. This included direct negotiation with the FDA to reach an agreement to correct the issues and get the company back in production.
Wyeth Pharmaceuticals, Guayama, PR
Project work on product contamination issue. Plant was closed after an issuance of a 483 and plant investigation could not find the contamination. Discovered the source as a bad bearing in a granulation system. Bearing was hidden from view and not a normal service part. Inclusive of required protocol write ups and recommissioning execution.
Gerresheimer, Worldwide Locations
Project work on numerous inspection and packaging systems as well as LEAN projects on FDA regulated Type I Borosilicate. This included groundbreaking work on inspection system development for Becton Dickinson on dental syringes and issues of ovality measuring to 0.0000 places. Required protocol write ups and commissioning execution.
Aluswisse, Worldwide Locations
Project work on numerous inspection and packaging systems as well as LEAN projects on FDA regulated Type I Borosilicate. This included many subcontracted projects for pharmaceutical companies like Alcon Pharmaceutical to deal with detection of defect issues that could have caused life threatening product consequences. Of note is that some of these installations still today rank as the largest installations of Robotics, Automation, and Quality Control on the North American Continent.
Wyeth Pharmaceuticals, Worldwide Locations
Project Work on numerous inspection and packaging and process systems to increase productivity, correct product failures and develop FDA required applications. This included the creation of products like Advil, the Today contraceptive sponge, and the Home Cholesterol Test kit. Product reformulations and scale up’s on products like Preparation H, Today Contraceptive Sponge, Premarin, Reglan, Robitussin, and Triphasil.
George H. Van Parys
PO Box 40014
Bay Village, OH 44140
sh6g9o@r.postjobfree.com
APPENDIX B: SELECTION OF FOOD & BEVERAGE SPECIFIC PROJECTS:
Gerresheimer, Worldwide Locations
Project work on numerous cullet conveyor systems, both dry and flooded. Additionally, innovative designs of converting farm conveyors to carrying batch material at 25% the cost.
Beverage Capital Corp., Baltimore, MD.
Project work on production lines running at 1800 PPM to reduce the product (Vitamin Water) temperature by 100 degrees in 55 seconds to prevent the ingredients from being rendered inert. Required protocol write ups and commissioning execution.
Ready Pack Foods, Barrington, NJ
Project work on pre packed salad conveyor lines to increase accuracy of product contents and increase total output of the facility. At the same time, work was completed to remove potential areas on equipment where bacterial contamination could build up do to improper initial design by equipment manufacturers. This included installation of a new production line.
Dog Fish Head Brewery, Milton, DE
Project work on redesigning product packaging lines to increase thruput 16.9%. This increase realized a 3.6 million dollar per year increase in profits or the company with only a $250K investment. Required protocol write ups and commissioning execution.
Dietz & Watson Philadelphia, PA
Project work on cooking racks for hot dogs and sausages to improve service life of the racks themselves as well as remove the “crook” from the end of the food part.
Eddy’s Ice Cream, Baltimore, MD
Project work in Metrology to layout and a complete plant wide calibration system for all product related sensors thru the entire manufacturing process inclusive of CIP system verification. Required protocol write ups and commissioning execution. This work took the facility from start up to release for production.
Bacardi Bottling Corporation, Jacksonville, FL
Project work in packaging to eliminate product jams and other problems due to attempts to run oval containers on round bottle lines.
McCormick Spices, Hunt Valley, MD
Project work on fume vapor extraction system based on use of natural aeration bedding material. This work solved an EPA emissions violation.
Cargill Meat Solutions, Wichita, KS
Work on temperature monitoring of both large carcass and end product to assure optimum storage conditions. Required protocol write ups and commissioning execution.
Nu-Meat, South Plainfield, NJ
Project work on DI-Water system to kill bacteria on meat sections in both brine and tenderizer operations. Required protocol write ups and commissioning execution.
Kellogg’s, Blue Anchor, NJ
Project work on Eggo Waffle manufacturing lines and freezer lines for Mrs. Smith Pies. Work included batch control, temperature control, and SPC input analysis. Required protocol write ups and commissioning execution.
Cumberland Dairy, Bridgeton, NJ
Project work on redesigning of process flow and CIP systems on various milk related products, including work for Rita’s Water Ice and McDonalds Corp. Required protocol write ups and commissioning execution.
McDonalds Research Center, Classified location
Work on temperature storage systems to determine optimum storage conditions for items like lettuce and vegetable material.
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