Engineer Process

* ***** *. ***********

* ***** ******

Warwick, RI 02889

Home: 401-***-****

Email: acazra@r.postjobfree.com

* ******* ******** ** / ********** ENGINEER / TECHNICAL WRITER

Process Development * Product Development * Process Improvement * System

Design * Supervisory Experience * System and Equipment Validation *

Manufacturing Experience * Commissioning and Qualification * Team

Leadership * Factory Startup * Technical Writer * Chemical Processing

Experience

QUALIFICATIONS AND ACCOMPLISHMENTS

. Well-organized, results-oriented Chemical Engineer (B.S. degree) with

extensive experience in Product / Process Design and Process

Improvement.

. Developed a new product that accounted for $1.75 million in added

sales per year.

. Designed the chemical processing portion of a new factory and led the

startup of this $4 million joint venture in Indonesia.

. Installed a flow monitoring system that reduced scrap by 50% and

allowed multi-doffing, increasing customer satisfaction.

. Increased line speeds by up to 30% and increased equipment capacity by

33 to 67%.

. Wrote an interactive Excel spreadsheet that reduced machine scheduling

time from 2 - 3 days to 2 hrs.

. More than 5 years experience writing and executing validation

protocols for equipment and systems (IQ, OQ, FAT, SAT) as well as

Design Validation and Validation Turnover Packages. Validation work

has included AMF Mixers, Sortomat Pill Sorter, tablet transfer

equipment, a Patterson-Kelley Blender and automated HPLC equipment.

. Familiar with cGMP procedures as they pertain to the Pharmaceutical

industry.

. Experienced with writing Change Controls, Standard Operating

Procedures (SOPs), and Unplanned Deviation Reports. Experienced with

the corrective and preventative action (CAPAs) process.

. Managed projects with Microsoft Project software while at Hart Design.

1 PROFESSIONAL EXPERIENCE

Fougera Pharmaceuticals, Inc., Hicksville, N.Y. January 2013 -

May 2013

Process Engineer - (3 month contract through Protocol Link)

Authored PPQ (Process Performance Qualification) reports to qualify

the use of the newly installed chilled water system used in the

manufacturing of topically applied creams and ointments. This task

typically involved closely interfacing with QA and QC as well as data

mining, processing the data through Excel and PPQ report writing.

Reduced the remaining project completion time by more than 50% for the

client at turnover by gathering and processing all the historical data

and providing a report template for each remaining item to be

evaluated. Wrote engineering study protocols for filling, packaging

and batch mixing equipment, as well.

Exemplar Pharmaceuticals, LLC, Fall River, Massachusetts April 2012 - Oct

2012

Process Engineer - (Contract)

Wrote and revised Standard Operating Procedures for equipment and

systems (i.e. pumps, homogenizers, filling equipment, propellant

delivery) used in the development of nasal and inhalation products

(i.e. MDI, DPI and nasal sprays). Experienced with writing Change

Controls and with determining and conducting Corrective and

Preventative Actions (CAPAs). Wrote and executed IQ, OQ, and PQ

protocols for equipment (i.e. stability chambers) used to store client

API. Wrote final reports summarizing the details of the executed

protocols.

VARIAN, INC., Wakefield, Rhode Island

April 2007 - Oct 2010

Process Engineer II (Contract) - Pharmaceutical and Biotech (HPLC

systems)

Provided system design and engineering assistance in the construction

of automated factory scale HPLC equipment for the Pharmaceutical and

Biotech industry. Provided the design qualification and turnover

package documentation. Provided documentation execution services on

the completion of the equipment both at our facility (IQ, OQ and FAT)

and at the customer's facility (SAT, IQ and OQ). The FAT and SAT

protocols included Performance Qualification (PQ) validation. All

projects assigned were completed on time and within budget.

. Developed P&IDs, equipment specifications, equipment lists, and

instrumentation lists for automatic factory scale HPLC equipment.

. Formed a design team to insure the equipment design would meet

customer needs. Worked with the fabrication shop throughout the

construction phase of the project.

. Authored and executed FAT, SAT, IQ and OQ protocols for the projects

(3+ years experience).

. Provided electrical wiring diagrams as well as doing the actual

wiring.

. Provided validation protocol writing and execution services for the

HPLC software as well as programming of the software to run the

HPLC equipment and updating of the software manual.

THE HOME DEPOT, Coventry, Rhode Island

March 2005 - April 2007

Department Supervisor

Worked in retail as a Department Supervisor managing three

departments: Kitchen and Bath, Appliances, and Plumbing. This consists

of managing department employees, product ordering, shelf stocking,

and unloading freight, calling on open orders, customer service,

placing special orders, department resets, and inventory shrink/swell.

I managed 8 employees in the Kitchen and Bath/Appliances Department

and 3 employees in the Plumbing Department. Assisted with the startup

of the new store in Coventry, RI by stocking and setting the store as

well as managing employees.

HART DESIGN GROUP LTD., Cumberland, Rhode Island

May 2001 - July 2004

Process Engineer/Validation Engineer

Provided process system design and process engineering support to

pharmaceuticals manufacturers, biotech industries and semiconductor

manufacturers. Provided validation support assistance by writing

protocols for equipment, systems and areas. Managed projects with

Microsoft Project software.

Process Engineer - Pharmaceutical, Biotech, Semiconductor

. Designed a bulk unloading system for liquids from tanker trucks.

. Provided a skid design for biological odor control.

. Developed P&IDs, equipment specifications, equipment lists,

instrumentation lists and line lists for a pilot plant expansion.

. Designed a bulk solvent waste storage and disposal system.

. As an on-site contract Project / Process Engineer to a client

company (Pfizer), I provided "as built" P&IDs of their Central

Utilities Building and the associated systems.

Validation Engineer - Pharmaceutical, Biotech, Semiconductor

. Wrote Project Validation Plans, Installation Qualification,

Operational Qualification and Process Qualification protocols for

equipment (AMF Mixers, Sortomat pill sorter, tablet transfer

equipment and a Patterson - Kelley Blender), systems (HVAC) and

areas (construction upgrades including materials, lighting and fire

protection).

. Provided on-site assistance as a contract Project Engineer at Amgen

for the construction of a pharmaceutical laboratory by leading a

team of three engineers assembling a Turnover Package including

welding and welders certifications, material certifications, piping

and valve certifications for type and materials of construction,

and "as built" P&IDs.

. Conducted System Level / Component Level Impact Assessments to

determine if commissioning or validation was required for equipment

and systems.

OTHER EXPERIENCE:

GLOBE MANUFACTURING CO., INC., Fall River, Massachusetts

May 1979 - Sept 1999

1 Process/Product Development Engineer - liquid latex compounding

Developed new products for and provided assistance to Production

keeping equipment and process operating properly. Improved product

quality by improving processing methods and ingredient preparation

techniques. Managed four technicians. Wrote instructional manuals and

procedures (SOPs) for ISO 9001.

. Increased the productivity (line speed) of over 30 items by 10% to

30% utilizing designed experiments (DOE) and equipment

modifications.

. Improved batch mixing techniques, including converting from manual

to automatic PLC controlled batching to provide more consistent

batches.

. Assisted in the installation of a flow monitoring system, which

reduced scrap 50%, allowed multi-doffing and improved customer

satisfaction.

. Designed the entire latex compounding system including designing

the chemical processing portion of the new factory and led the

startup of this $4 million joint venture in Indonesia.

. Led the startup team of the Indonesian Plant. The plant startup

was on schedule with saleable product giving us a one year

advantage over the competition.

FULFLEX INC., Bristol, Rhode Island

Feb 1977 - March 1979

Product/Process Development Engineer - hard rubber compounding

Revised the product formulations in the textile thread area for R+D to

reduce product cost.

Streamlined the shipping and receiving operation in their southern

plant. Optimized batch mixing procedures and worked with maintenance

to insure the equipment was operating properly to maintain product

consistency. Managed the raw material ordering.

2 Quality Engineer

Performed raw material inspection and worked with suppliers to solve

technical supplier problems and assure receipt of quality materials.

OWENS CORNING FIBERGLAS, Granville, Ohio

June 1973 - Jan 1977

1 Product/Process Development Engineer

Developed/improved products in the Pultrusion area (e.g. fishing

poles, antennas, structural shapes) and developed coatings for the

fiberglass thread to improve compatibility with polyester resins.

Developed two coatings that were patented.

2 EDUCATION

. BS in Chemical Engineering, University of Rhode Island - 1973

3 COMPUTER SKILLS

. Microsoft Access

. Microsoft Excel

. Microsoft Word

. Preliminary training in Solidworks 2D and 3D

. Microsoft Project

4 ADDITIONAL TRAINING

. Managing the New Product Development Process (WPI)

. The WPI Teambuilding Workshop, FMEA, DFMEA and DOE

. Lean Six Sigma and Project Management

Contact this candidate