John L. Miller

* ******** ***** . ******, ** ****5

Home: 610-***-**** . E-mail: abk7uw@r.postjobfree.com . Cell: (610)

***-****

Senior PROJECT MANAGEMENT

* ****** ******* **********, *****ct Development, Process Design,

Engineering and Problem Solving Skills

2 to Add Corporate Value in the Biotech and Pharmaceutical Industries

A versatile Mechanical Engineer with a track record of adaptability to

Biotech and Pharmaceutical process design, project management, facilities,

engineering, product development, sales and marketing, budgeting,

validation documentation and protocols. Strong organizational skills

provide the ability to take on challenging tasks and complete them with

minimal resources. With great interpersonal, problem solving,

organizational and communication skills that allow effective interaction

with individuals at all levels. Utilizes in depth knowledge of fluid flow,

thermodynamics, material selection, electromechanical components, standard

engineering practices, principles and team input to resolve difficult

problems from conception to final design. Results-driven commitment to

corporate objectives. Strengths in:

New Product Design/ Development Communication and Teamwork

Organization & Planning Customer Relationship Management

P&L / Financial Control Effective and Proactive Leadership.

Systems Engineering & Integration Proposals / Contract Negotiation

Project Management Vendor Selection and Negotiation

2 Computer Skills

Programmer, Consultant and Beta tester with extensive experience in

numerous Macintosh and Windows software applications. Some of the programs

I used are as follows: SAP, EDMS systems (ADEPT), AutoCad, SolidEdge,

Versa CAD, CadKey, PageMaker, PhotoShop, MS Project, Harvard Project, MS

Excel, Lotus 1-2-3, Mac Write, MS Word, & WordPerfect.

3 Professional Experience

2 Independent Consultant, Easton, PA 2008-Present

(Process engineering, controls engineering, design, procurement,

fabrication, testing, installation, commissioning, and validation for the

Pharmaceutical Preparations industry)

SENIOR PROJECT Manager

Manage project assignments with a broad scope and high level of complexity

leading a diverse highly technical team with multiple disciplines to

prioritize and achieve aggressive on time product delivery.

Effective in developing creative solutions for applications by utilizing

experience and contacts that enabled the company to secure new business in

a highly competitive market.

Review incoming inspection data a custom parts and resolve quality problems

to insure GMP and FDA compliance.

Responsible for a number of multi-million dollar projects which included

engineering, designing, purchasing parts, fabricating, testing and

installing the completed equipment.

Performed specification review and preliminary process design, estimated

material and labor to generate proposal and CAD P&ID and PFD drawing(s).

Investigated and performed value analysis/ design of products associated

with injection molding and extrusion machines.

Project management and design for electro-mechanical system involving

chemicals, piping, steam and complex control systems.

3 Sartorius Stedim Biotech, Bethlehem, PA 2002-2008

(Leading provider of cutting-edge equipment and services for the

development, quality assurance and production processes of the

biopharmaceutical industry. The division relocated to Missouri after 2008)

SENIOR project engineer/ Manager, applications, NEW PRODUCT DEVELOPEMENT

As the main Engineering contract for downstream processing I designed,

coordinated planning, directed personnel, developed budgets, provided field

support, prepared schedules, work plans, quotations and resource

utilization, required to support both the Sales and Project Management

Engineering requirements for the product line to meet the demands of the

United States market. In addition, I performed both Applications and

Project Engineering duties for upstream processing.

Researched and developed disposable designs for downstream processing

equipment.

Provide direction and technical decision making, research, develop, process

engineering, field service, repair, designed, verified and developed for

improvements to existing and new products, processes, equipment, and

technology to support downstream processing.

The engineer assigned to relocate the facility from Allentown to Bethlehem

with minimal time and resources, negotiated, supervised contractors,

participated in meetings with the general contractor and local officials.

A key factor in the design and layout of the boiler room, plating line,

pure steam generator, USP purified water system, water softener system, oil

free air compressor, shop floor piping and workstation layout, service room

layout, warehouse layout, electrical and all piping utilities.

Interfaced with Customer and Engineering Firm to complete process

calculations, negotiate with vendors, prepare validation documentation,

manufacturing/ inspection procedures and protocols, led/ managed multi-

discipline and multi-office teams in engineering, manufacturing and design

for a multimillion-dollar project so efficiently that the profit exceeded

200% of the sales estimate.

Directed proposal development, prepared specifications, standard proposal

format, brochure/ datasheets, drawings, quotations, equipment costing,

operating manuals. Participated in meetings, generated presentations,

performed customer phone support to aid sales efforts.

Organized process validation activities, documentation and validation

oversight for existing and new product introductions by creating and

executing SOP, FAT, IQ, OQ, PQ & SAT protocols to satisfy local, federal

and industry regulatory requirements in-house and in the field.

Optimized material and design of existing and new products to improve

operation, uptime, efficiency, reliability, maintenance access, training

assessment needs, installation correlation to design, ease of scale-up,

while decreasing parts usage, labor hours and equipment cost for increased

value to the end user.

4 Aqualogic - FPI Systems, North Haven, CT 1998-2001

(Washers, Electronic Components, Electroplating Control Systems, Aerospace

Precision Components, Automated Metal Finishing Equipment, Cleaning

Systems, Chemical & wastewater treatment, recovery, cleaning & process

equipment for the finishing industry. FPI Systems was closed due to the

financial crisis)

SENIOR project engineer, NEW PRODUCT DEVELOPEMENT (2001-2002)

Performed process design and project management for various systems. As

defined by the Companies Standard procedures the Engineer was to do

everything. I developed costing, specified system components, created

electrical and mechanical CAD drawings, developed specifications, selected

and specified all components, purchased and inspected all material, hired

contractors, supervised contractors during installation, supported/

trained the customer in the field and created installation & operation

manuals for National and International projects.

Designed, built, installed and trained customer on a custom state of the

art closed loop waste treatment system that incorporated many technologies

including, oil water separation cold lime process, sedimentation, filter

press, micro-filtration, carbon filtration, two pass reverse osmosis,

centrifuge, evaporation that produced high quality water for a large

electrical panel parts washing system.

Developed, designed and built a new standard micro-filtration product that

won a product of the year award.

5

6 US Filter - Penfield - Impulse, Plantsville, CT 1992-1997

(Provided many different types of water treatment systems, major supplier

to the Pharmaceutical industry. Company relocated to Colorado after 1998

and was purchased later by Siemens)

SENIOR project engineer, Manager (1994-1997)

Accustomed to being assigned the more difficult custom projects I

successfully managed every assignment with efficiency. Working with

multidisciplinary teams in engineering, drafting and manufacturing to

complete the process design, prepare process flow (PID) diagrams, select

and purchase components required by proposal/ specification, finalize the

mechanical and electrical assembly drawings, prepare operating manuals,

manage fabrication and production of the equipment to completion and

executing factory acceptance testing for final approval prior to shipment.

Directly interfaces with customer to manage the coordination and

collaboration of project information for a custom advanced industrial

electro-mechanical system, reviewing the specification and proposal to

conceptualize the system design, organize the resources, timing, and costs

of the activities, organize a team of engineers, draftsmen and assembly

personnel and supervise the creation of validation documentation to deliver

the system two weeks early and under budget.

7 Impulse Regeneration Services, Hatboro, PA - Cheshire, CT 1992-1994

(Startup based on patented technology for improving regeneration efficiency

of ion exchange resins used in industrial and commercial water treatment.

Company integrated into parent organization Penfield late 1992 and then

sold to US Filter 1994)

2 Senior APPLICATIONS ENGINEER, NEW PRODUCT DEVELOPEMENT

Pivotal strategic planning and business development role for the execution

of the sales, marketing and engineering efforts for the product line.

Executed and supported the strategic marketing plan to introduce the

product to various customers while working closely with a national

representative organization.

Key factor in quotation development, sales support and training, process

design, costing and specification development that produced over one

million ($1,000,000) in sales in second year.

Interfaced directly with the regional sales managers and representatives to

gather information on the customer requirements and the competition to

generate the product specification.

Involved in directly answering customer calls, generating sales leads,

creating proposals and managing the project after sale.

Originated system sizing program, master proposal documents and assisted

with most of the literature for the product line.

Organized the completion of the standardization of the product line while

working closely with R&D and the engineering teams.

Prepared quotations for custom Pharmaceutical systems.

1 Crane Environmental, King of Prussia, PA 1991-1992

(Leading supplier of specialized purification solutions for the world's

industrial and commercial markets. Worldwide applications include oil,

gas, petrochemical, power generation, desalination, general industrial,

institutions, bottling, beverage and government)

SENIOR applications engineer

In support to the new products manager, I proposed water treatment

equipment from the initial stage, supervised drafting, electrical

engineering through the design, and manufacturer of the system and then

went into the field and started up the equipment.

Managed national accounts with McMaster-Carr and W.W. Granger, assisted in

putting together marketing strategies, new brochures and worked with a

National Sales Force of Representatives.

Demonstrated skills and abilities to effectively market and coordinate the

sale of assigned products through a national representative group to manage

projects and resolve company/customer related technical issues.

1

2 Education & Professional Qualifications

1 B.S., MECHANICAL Engineering

Drexel University, (1989)

CERTIFICATES:

Microsoft Project, Working with Teams

ON THE JOB TRAINING:

SAP, Project Management, Piping Design and many vendor components.

3 Tasks Performed

Work with A&E firm, ASME design, air design, annual sales forecasting,

applications engineering, automation, bid award, billing, black iron

design, budget for equipment assets, budget for maintenance, business

development, carbon steel design, chemical, chemistry, cGMP Compliance,

clean rooms, concrete design, copper design, cost tracking, customer

relationship building, designed and installed boiler room, develop

specifications, develop P&ID and PFD, DIUF, electrical design, ECN

paperwork, estimating, facility design, design control, design and

installation, field installation, financial reports costing, functional

requirements specification, gas design, hoists, hydraulics, install

equipment, international and local team work, invoicing, lined piping

design, make profit, managed contractors, mentor, negotiating change

orders, new product development, organization, materials, P&L, plastic

piping design, PLC & Delta V controllers, pneumatics, presentations,

pressure vessel design, process description, process design, process

fluids, process scale-up, process validation guidelines, project

management, proposals, purchasing, quality system regulation (QSR) - QA -

SOP, FAT, IQ, OQ, PQ & SAT protocols/ execution, regulatory, sales calls,

sewer design, specification review, stainless steel design, standards,

steam design, supervision duties, technical support, TOP- turn over

package, train customers, train personnel, underground drain system,

utility design, vendor negotiation, USP VI, US FDA and ISO drawings,

validation, WFI, write operating manuals.

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