PROFILE:

• Various positions in Global Operations and Engineering with 3 / 5 BS degrees and a Six Sigma Master Black Belt.
• Oversaw the design and Project Management of the largest installations of Robotics, Automation, Manufacturing & Quality Control in the world.
• Design and implement projects up to 2 billion USD (individually) around the world.
• SME for the Confidential, expert on Confidential .
• Extensive experience in Pharmaceuticals, Medical Devices, Sterile Syringes, Plastic Injection & Blow molding & Pharma Glass.
• Extensive Packaging experience including thruput optimization and sterilization of Medical Devices.
• Aseptic filling and Packaging systems for parenteral drugs, including Aseptic clean rooms.
• Designed and installed over 425 Packaging lines, with 1279 pieces of automated Packaging inspection equipment.
• Hold 30 Pharma patents in North America, liquids and solids.
• 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. Holds 30 US Pharma Patents.
• Consulted with the Confidential to write sections of the cGMP’s including CFR211:122(section G) on line operations, Part 11 & 820.
• Currently involved in engineering, design, and implementation for regulated Industries throughout the US inclusive of Pharmaceutical, Bio - Tech, Food and Beverage, Chemical Mfg., along with Composite & BIO Chemical Mfg. As well as Confidential, Serialization and Track & Trace.

CORE COMPETENCIES:

• Validation / Risk / FMEA
• Multi-Site Operations cGMP Compliance
• Manufacturing Engineering
• Strategic Planning
• Project Management
• Quality A / C
• Facilities Maintenance
• Process Improvement
• ISO Requirements
• Lean Manufacturing
• Staff Motivational Training
• Production Control
• Manufacturing Operations
• Systems Automation
• Change Management

EXPERIENCE:

Confidential, Orange, CA

Responsibilities:

• Serve as technical expert for all aspects of packaging design and development as well as packaging improvements. Manage packaging related activities with all parties including internal and external supplier.
• Create formal procedures for the in corporation of Confidential labeling on all existing and new labeling
• Assist local site teams with the design, development, implementation, and approval of Confidential compliant product labeling and barcodes

Confidential, San Dimas, California

Responsibilities:

• Upgrading Packaging equipment to be able to create online inspection systems to be networked thru the plants computer backbone. 21 inspection systems with up to 8 cameras on each. This includes fabrication, augmentation, and new installations. Additionally, this includes, design, manufacturing oversight, and generation of all accompanying SOP's, URS, FDS, IOQ, PQ.

Confidential, Plainsboro, NJ

Responsibilities:

• Upgrading Packaging equipment to reduce reject rate and increase thruput thru equipment modification, augmentation, and new installations.
• This includes, design, manufacturing oversight, and generation of all accompanying SOP's, URS, FDS, IOQ, PQ, etc.
• Numerous CAPA projects on all aspects of Manufacturing, Packaging, Training, HVAC and other facility issues.

Confidential, Bedford, OH

Responsibilities:

• Including but not limited to URS, FDS, CQ, COQ, IQ, OQ, PQ. Equipment manuals and SOP’s. Both write up and execution.

Confidential, Brighton, CO

Product Development, Senior Specialist, Robotics & Automation

Responsibilities:

• Hands on major work on robotics & automation 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.

Confidential, Wilmington, DE

Project Management

Responsibilities:

• 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 Confidential / 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, Packaging and facility operations.
• Major, White Paper analysis on production issues around cross-contamination & changeovers.

Confidential, NJ

Operations Manager / Lead Engineer

Responsibilities:

• Projects directly related to Confidential 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.

Confidential, Vineland, NJ

Manager, Process / Engineering

Responsibilities:

• 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.

Confidential, Millville, NJ

Manager, Process / Engineering

Responsibilities:

• 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.

Confidential

Manager, Systems and Security Engineering

Responsibilities:

• 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

Confidential

Responsibilities:

• Installation of over 150 Packaging line inspection stations in three manufacturing facilities. Installation of various Packaging and manufacturing lines in all Confidential . Product reformulations on products like Reglan, Robitussin, and Triphasil.
• Facilities projects varying in value from three to five million dollars.

Systems Engineer

Confidential

Responsibilities:

• 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.