G ilberto I nserni P.E.

Paseos de Jacaranda, ****8 Calle Maga I-19, Santa Isabel, Puerto Rico 00757-9628

TEL: 787-***-**** / 787-***-**** / 787-***-**** ext. 6548 / ab837d@r.postjobfree.com

RESULTS-DRIVEN SENIOR PROJECT AND PACKAGING ENGINEERING MANAGER

Extensive expertise in all conventional aspects of Project, Packaging, Process, Plant, Facilities, Mechanical,

Engineering Processes, Aseptic and Lean Manufacturing practices.

PE-licensed Project Manager with broad practice directing large-scale Pharmaceutical projects.

Can direct complex, multiphase and high-profile Engineering projects. Able to address financial constraints and

complicated logistics to overcome project challenges.

Excel in meeting or exceeding design, quality, timeline and budget expectations.

Pharmaceutical/ FDA, DEA, GMP regulated industry skills.

On-site plant knowledge of Safety, OSHA, and FDA regulations.

Expert in performing Process, Packaging and Equipment Validations.

Team and independently oriented, Excellent technical, analytical and problem solving skills, Can multi-task to set

and meet goals, experienced senior’s point of view, Strong Mechanical, Project and Packaging aptitudes.

PROVEN EXPERTISE

Packaging and Equipment Engineer Packaging Equipment expertise. Have expertly handled packaging and

production equipment including: Blister machines, Bottle filler

machines, Pouching, Labelers, Shrink wrapper, Cartoners, Cream filling

lines, Aseptic filling, and many others. Can successfully complete the

Installation, Inspection, and Safety parameters, Maintenance and

Optimization of Manufacturing Equipment and Solid Dosage. Can

expertly lead cross-functional teams.

Project Management Handled project planning, scheduling, cost control and economic

analysis, up to $14 M. Handled complete project cycle from conception

to completion, including but not limited to budgeting, acquisition,

modification, installation, specification, validation commissioning,

handover and training.

Engineering Designs 16 Years of Successful Engineering Conceptual Designs, along with

production equipment improvement, support and troubleshooting.

PROFESSIONAL EXPERIENCE

Pfizer Pharmaceuticals, Carr. Num. 3, Guayama, PR

2006 to Present -PRINCIPAL PACKAGING ENGINEER II/PROJECT ENGINEER

I create Technical Specifications and Technical Support of all design, device & delivery systems. I direct for Job

Performance and Departmental Effectiveness and Efficiency. Manage development of funds for Pharmaceutical

equipment. Perform all Utility, Facility and Equipment Improvements and Renovations for production support and

efficiency. Perform Green Building improvements. Developed Pilot project and installation of Wind Generators

and solar panels. Design and installation of 9,000 gl. Cooling Tower and a 8,000gl. completely automatic

Purifying Water System connected to BMS. HVAC Replacements for Primary Packaging rooms Class 10,000 and

100,000. Subject Matter Expert in design, operation and troubleshooting for HVAC.

Accomplishments

• Successful Conversion, Commission and Validation of Two Packaging Lines for New Product Development

within Budget and schedules for continuous improvement and productivity.

• Facility and Equipment Improvements in Plant Area so as to comply with FDA Inspections and increase

productivity.

• Implemented in-house Designs for Capital Projects without Contracted Services from other sources thus saving

the Company thousands of dollars.

• Wind study and installation of Wind Generator and Solar panels to generate plant power, saving hundreds of

dollars on electric bills.

Biovail Laboratories Internacional SRL, Dorado, Puerto Rico

2005 to 2006 PROCESS ENGINEERING MANAGER

Prepared budgets, managed Manufacturing Capital Project Funds. Gave support to Technical Operations in New

Product Transfer. Developed Improvement Projects for generic drugs. Considered an expert in AUTOCAD

Designs. Created improvements for Solid Dosage and Packaging Processes. Support for Blister Lines and Bottles.

Built a Pilot Plant for product development.

Pfizer Global Manufacturing, Arecibo, Puerto Rico 00612

1987 to 1990 / 2002 to 2006 PROJECT ENGINEER IN CHEMICAL PLANT

Prepared budgets and estimates, managed Chemical Plant and Capital Project Funds. Directly supervised the

implementation of Plant Capital Projects. Determined project Scope and User Requirements. Submitted Change

Controls and P & ID for New Projects. Gave maintenance and troubleshooting to Pharmaceutical Plant, Process,

Solid Dosage and Packaging Lines.

Accomplishments

• Created and directed project for the renovation of a 32 year old, 3 story Chemical building, so as to extend use

for the Production of Active Product Ingredients for product transfer, with the generation and implementation of

capital projects within and out of the building on schedule, exceeding expectations and within budget.

•Direct the Engineering Department for the generation, construction and field supervision of Capital Projects in

order to meet the reduction of the total expenditures and meet schedules.

•Total inventory of Assets, achieving the elimination of 2MM dollars in Equipment Depreciation.

•Recognized as Subject Matter Expert on Design, Specifications, Installation, Inspection, Maintenance,

Optimization, Troubleshooting, Validation Protocols. Packaging, cGMP’s and SOP’s practices.

•Achieved total success in handing difficult and complex projects.

Ortho Pharmaceuticals, Manatí, P.R - 1990 to 2002

2000 – 2002 EQUIPMENT ENGINEERING MANAGER

Performed as an Engineering Specialist in Lean Manufacturing Processes. Supported and provided engineering

services to a demand pull production environment. Prepared and managed CIP projects for Packaging lines

automation and replacement.

1993-2000 DIALPAK TECHNICAL EXPERT (Special Assignment)

Assigned to a Special Project in Oct. 1993, that consisted of designing, buying, installing and optimization of a

two high tech Blister packaging line. Two years of design were at the New Jersey facility.

1990-1993 EQUIPMENT ENGINEERING MANAGER

Successfully executed the installation and qualification of Semisolid and Solid packaging lines.

Accomplishments

Exceedingly improved packaging assembly line to exceed expected output by 75%.

Broad Participation in the Implementation Project for Lean Manufacturing as Packaging Expert, from its Design

to Completion and identifying problems so as to Increase production.

Represented Ortho in Switzerland Operations in order to apply benchmark of initiatives and methods as to

Improve Lean and OEE Processes for Corporate advantage.

Evaluated, proposed and executed technical solutions to Manufacturing and departmental/corporate issues to

reduce costs, optimizing production thus increasing profits.

Completed the Dialpak 14M Project within Budget and surpassed projected production.

Created Protocols and Qualifications for Cream and Tablet Packaging Lines without contracted services from

other sources thus saving the Company at least $250,000.00.

Two times Awarded with Johnson & Johnson Achievement Award

EDUCATION, TRAININGS, LICENSES AND MEMEBERSHIPS

University of Puerto Rico, Mayagüez Campus, Mayagüez, Puerto Rico

•BS Mechanical Engineering / Minor in Electrical Engineering

Colegio de Ingenieros y Agrimensores de Puerto Rico, San Juan, Puerto Rico

•Civil Engineering Certificate, 1987

•Fundamental Project Management Certificate, 2006

•Professional Engineer License Num. 9402 in PR

Available for Relocation & International Travel

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