Engineer Project Management
Resume:
Edgar N. Gutarra Negrón
Juan Sánchez, Bayamón
Puerto Rico 00959
Mobile: 787-***-****
************@*******.***
Hi:
I am interested in a Direct Hiring or Consultant – Professional Services position for your
organization. I am a professional seeking for companies where my accomplishments and
proficiency will allow the opportunity to enhance and develop the knowledge and skills in
contributing to excel of your organization.
I have received a BSChE degree of the University of Puerto Rico, Mayagüez Campus on
December 1994. In the present, I am working as independent consultant (ENGN Professional
Services). I have more than 15 years of working experience on Medical Device, Electronic,
Biopharmaceutical and Pharmaceutical Industries in the areas of Project Management, Process
Support, Troubleshooting, Validations and QA/QC.
I have experience as a consultant on the areas of Validation, Project Management, Engineer and
QA/QC. My experience includes but not limited on the generation, revision and execution of
Site Capital Plan, Project Coordination, Design evaluation, EHS activities, Finance request and
Liaison, Validation Master Plan, IQ/OQ/PQ for temperature mapping, computer system, PLC,
autoclave, facilities and utilities (HVAC, Water System (WFI, SW, RO), CIP, SIP, CA),
formulation, manufacturing equipments, packaging equipments and Laboratory equipments
(HPLC, UV/Vis, GC, Atomic Absortion, Calorimeter, etc). Also, I had being directly involved
on SAT/FAT/CSV, Injection Molding, Product and Process Improvement, Complaint
Investigation, CAPA implementation, P&ID and Isometric Development and Verification,
Control System (BMS, PLC) and Vendor Audit.
I am highly motivated and posses the knowledge and stamina to undertake the most
challenging situations. I am a team worker, self-starter with proven leadership qualities and
good troubleshooters.
As a first step, I enclose my resume for your evaluation. We are available to meet you to
discuss ours qualifications at your convenience. ENGN Professional Services would like to
thank you for your time and any consideration you may give us. I look forward to hearing from
you.
Respectfully yours,
Edgar N. Gutarra-Negrón, BSChE
ENGN Professional Services
Professional Summary:
Over twenty (20) years experience in qualifications and validations activities for the
pharmaceutical, medical device and electrical industries on the Engineering and Quality
Departments.
Experience in Project Management, Master Plan Development, Construction Activities,
Validation Activities, Investigations, Technical Support, Process Improving, Complaints
Investigation and Troubleshooting.
Education:
University Of Puerto Rico, Mayagüez Campus 1989 – 1994
BSChE (Chemical Engineer) Magna Cum Laude
Professional Experience:
Position: Project Management and Validation Consultant
Independent Consultant- ENGN Professional Services
Period: 2003 to Present
Project Management System Administration
Solid and Semi-Solid Dosage Process Investigation and Improvement on the
areas of Weighing, Glove box, Mixing, Drying, FBD, Compressing, Filler
Bottle/Blister Machine and Packaging equipment and process.
Solid and Semi-Solid equipment and control system selection and
installation.
FIKE and F-200 Fire suppression system selection and installation
supervision.
Liquid Processes investigation and improvement including extraction,
purification, filtration, roller bottle filling and packaging processes.
Solid, Semi-Solid and Liquid parameters optimization based on complaints
investigations, CAPA, energy saving, EHS observations, Engineering
controls, automatization, data analysis and/or direct observation.
Solid, Semi-Solid and Liquid manual processes analysis, standardization and
automation as applicable.
Management of Utilities Projects including but not limited to construction,
installation, commissioning, qualification and validation of Chillers,
Dehumidifier, HVAC System, Nitrogen equipment and utility, Compressed
Air equipment and utility, Dryers, Purified Water System, Soft Water System,
Water for Injection, Clean Steam System, Clean In Place, Steam In Place,
Evaporator, Dust Collector system and facility Room, Site Vacuum system,
Chiller Facility, Chemical Room Facility, Building Management System,
Utilities Control System and other.
Management of Facilities Projects including but not limited to construction,
installation, commissioning, qualification and validation of Manufacturing
rooms, Packaging rooms, Chemical Storage room, Flammable Storage room,
Dust Collector room, Utility area Enclosure and other. Rooms were either
new construction or modification to existing ones that includes installation or
modification to ceiling, floor, doors, partition, wall covering, sprinkler
system and utilities.
Management of Energy Conservation Project including but not limited to
evaluation, installation and commissioning of Solar heater system,
manufacturing areas lighting, warehouse areas lighting, Administrative area
lighting, Utility Area lighting, areas present sensors, rooms painting, ceiling
height, Air Changes, Relative Humidity/Temperature parameter evaluation,
Electrical Panels evaluation and analysis and other.
Management of EHS Compliance Project including but not limited to
evaluation, installation, construction and commissioning of Lifelines system,
Grounding System, Fike System, Anchor Points, Rooms Containment, Laser
Engraver Room, Waste room, Sprinkler System, Potent Drug room
conversion, Electrical Panel Identification and other.
Management of QA Compliance Project including but not limited to
evaluation, installation, construction and commissioning of Self
Containment, Cross contamination and Cleaning Surface remediation plan,
Laboratory Equipment replacement, Rooms Layout and other.
Client: ENGN Services Consulting services provided to Shire - Lexington.
Period: 06/2013 to Present
Task:
Building Management System (BMS) Evaluation
Process Control System (PCS) Evaluation
System and Software Development Life Cycle (SDLC) Evaluation
Hazard Analysis and Critical Control Points (HACCP) Analysis
Critical Quality Attributes (CQA) Determination
Critical Process Parameters (CPP) Determination
Alarm Rationale and Prioritization
BMS and PCS Remediation Plan
Client: ENGN Services Consulting services provided to Hospira- North
Carolina.
Period: 04/2012 to 01/2013
Task:
Develop Supplier Quality Investigation Plan
CAPA Implementation
Aseptic Process and Product Investigation
Parenteral Product and Commodities Investigations
Sterilization Processes (Heat, ETO) Investigation
Complaints Investigation
Supplier Quality Investigation Team Lead
Vendors/Suppliers Evaluation
Client: ENGN Services Consulting services provided to Abbott Laboratory-
Jayuya.
Period: 04/2008 to 04/2012
Task:
Talent Recruiter
Turn Key Project Management (Conceptual thru Validation Activities)
Capital Plan Develop and Administration
Capital Request
Design evaluation
Bidding Process Coordination and execution
Project Management
Liaison between construction contractor, validation consultant and client
Liaison between Engineering Department and Design companies
Liaison between Engineering and Finance Department
Liaison between Engineering, IT, QA and EHS Department
Responsible for budget and projects scheduling
Requisition and Purchase Order creation and evaluation
Construction and Validation Proposal evaluation and coordination
EHS representative on projects
Execute Purified Water System qualification and validation
Implement Site Building Management System (IQ/OQ/PQ/CSV)
Construction of Manufacturing area to comply with FDA and Regulatory
Agencies regulations for Potent Drug
Energy conservation projects implementation
Process Improvement Projects implementation
CAPA evaluation and implementation
Develop, evaluate and preparation of SOP and Validation Activities
(IQ/OQ/PQ) for BMS, Utilities, Control System, Manufacturing and OSD
Packaging Processes and equipment
Develop, evaluate and prepare IQ, OQ and PQ for automated control system,
experience with PLC and Microprocessors
System Develop Life Cycle(User and Functional Requirements, FAT and
SAT)
Client: ENGN Services Consulting services provided to Aventis
Pharmaceuticals - Manati / INyX – Manati
Period: 01/2006 to 12/2008
Task:
Project Management
Construction and Validation Activities coordination
Responsible for budget and projects scheduling
Construction and Validation Proposal Evaluation
Design evaluation
Temperature Mapping (Digistrip, Validator 2000)
System Develop Life Cycle (FAT, SAT, User and Functional Requirements)
Develop, evaluate and preparation of SOP for BMS, Utilities, Control
System, Manufacturing and Packaging Processes
Develop, evaluate and preparation IQ, OQ and PQ for automated control
system, experience with PLC and Microprocessors
Develop, evaluate and execute the HVAC and control system IQ/OQ/PQ
Protocols.
Update P& ID and Isometric for product contact utilities (PW/SW/CA/WFI)
Coordination and Supervision of Project Contractors and Validation
Consultant
Evaluate and update Process and Instrumentation Diagrams (P&ID) and
Isometric drawings for product contact utilities (PW/SW/WFI/CA/Nitrogen)
Laboratory Equipment installation and qualification (Autoclave, HPLC, GC)
Autoclave load design
Investigations and CAPA Implementations
Client: ENGN Services Consulting services provided to OBI – Manati / Ortho
Pharma – Manati
Period: 02/2005 to 11/2006
Task:
Project Management
Construction and Validation Activities coordination
EHS representative on projects
Temperature Mapping (Digistrip, Validator 2000)
System Develop Life Cycle (FAT, SAT, User and Functional Requirements)
Develop, evaluate and preparation of SOP and Validation Activities
(IQ/OQ/PQ) for BMS, Utilities, Control System, Manufacturing and OSD
Packaging Processes and equipment
Develop, evaluate and preparation IQ, OQ and PQ for automated control
system, experience with PLC and Microprocessors
Perform Product OOS investigations
Product and Manufacturing Process Improvement investigation and
implementation
Evaluation of Aseptic Areas and processes
Develop, evaluate, prepare and execute IQ/OQ/PQ Protocols for Utilities
(CIP, SIP, HVAC, CA, WFI, PW, SW and other), Manufacturing, Liquid
Filling Packaging and Laboratory Equipments and Facilities Qualification.
Evaluate and update Process and Instrumentation Diagrams (P&ID) and
Isometric Drawings
CAPA Implementation
Complaints Investigation
Vendor Audit
Client: ENGN Services Consulting services provided to Merck – Barceloneta /
McNeil – Las Piedras / Pall Sciences – Fajardo
Period: 01/2004 to 12/2006
Task:
Project Management
Construction and Validation Activities coordination
Construction and Validation Proposal Evaluation
Design evaluation
Develop, evaluate and preparation of the Projects Master Plan
Evaluate and update Process and Instrumentation Diagrams (P&ID)
Evaluate and update Isometric Drawings
CAPA Implementation
Manufacturing Process Optimization
Complaints Investigation
Blister Packaging IQ/OQ/PQ
Member of the audit/evaluation team responsible for the identification and
implementation of remediation activities to answered FDA Audit
Utilities, Facility, Cleaning and SOP Audits
Client: ENGN Services Consulting services provided to ROVI Pharmaceuticals
– Madrid, Spain
Period: 10/2003 to 02/2004
Task:
Project Management
Develop and prepare Pharmaceuticals Master Plan
Develop, evaluate and preparation of the Projects Master Plan
Responsible for budget and projects scheduling
Construction and Validation Proposal Evaluation
Design evaluation
Validation Activities coordination
Audit ROVI Pharmaceuticals for cGMP and FDA compliance
Develop, evaluate, prepare and execute IQ/OQ/PQ Protocols for Utilities
(CIP, SIP, HVAC, CA, WFI, PW, SW and other)
Position: Validation Consultant
IMC
Period: 02/2002 to 12/2003
Client: Consulting services provided to Pfizer Pharmaceutical - Barceloneta
Task:
Evaluate and update Process and Instrumentation Diagrams (P&ID) of
Solvent Recovery (NUCON) System
Prepare, evaluate and execute FAT/SAT/IQ/OQ/PQ of Solvent Recovery
System (NUCON) including control system
Execute IQ/OQ of the Solvent Recovery (NUCON) System, which includes
control valve, rupture disk, Regulator valve, Relief valve, Tanks, Heat
Exchanger, LEL and Oxygen Analyzer, NUCON and related instrumentation
Prepare, evaluate and execute FAT/SAT/IQ/OQ/PQ of New Generation Tablet
sorter/handler/LASER drilling equipment and it control system
Position: Validation Consultant, Foster Wheeler Ltd.
Period: 08/1998 to 02/2002
Client: Consulting services provided to Ortho Biologics - Manati, Merck -
Barceloneta, Schering - Manati and Amgen - Gurabo
Task:
System Develop Life Cycle (FAT, SAT, User and Functional Requirements)
Develop, evaluate and preparation of SOP and Validation Activities for
Utilities, Control System, Manufacturing and Packaging Processes and
equipment
Develop, evaluate and preparation of IQ, OQ and PQ for automated control
system, experience with PLC and Microprocessors
Evaluation of computer controlled system for CFR Part 11 Compliance.
Execute IQ/OQ of the control valve, rupture disk, Regulator valve, Relief
valve, Tanks and related instrumentation
Prepare, evaluate and update Process and Instrumentation Diagrams (P&ID)
of Utilities and Product Lines
Prepare, evaluate and update Isometrics Diagrams of Utilities and Product
Lines
Verification and evaluation of Electrical Drawings
Prepare, coordinate, execute and evaluate the qualification and validation
activities for Air Handling Unit serving Warm Room including drawings,
P&ID, compressor and motor performance, operational parameters, process
instrumentation, electrical utility, drainage utility, chilled water utility, hot
water utility and ductwork
Prepare, coordinate, execute and evaluate the qualification and validation
activities for Air Handling Unit serving Honeywell Excel 500 control system
including controller environmental, security and Y2K, structural program
examination, discrete/analog input /output test, alarms test, control loop
performance and HVAC balance test and SOP verification
Evaluation of Y2K Compliance of packaging equipment
Prepare, coordinate, execute and evaluate the qualification and validation
activities for Laboratories and Process equipment, including UV, HPLC,
Calorimeter, Ovens, Autoclave, Roller Bottles Machines, AHU, Rooms
Certification and Freezers
Prepare, coordinate, execute and evaluate automation protocols for
Laboratories equipment, including UV/Vis, HPLC and Calorimeter
Position: Validation Engineer, Mentor Caribe - Medical Device
Period: 06/1996 to 08/1998
Task:
Prepare, coordinate, execute and evaluate the qualification and validation
activities of the Formulation and Fabrication Processes. Including polymer
formulation, lathing process, milling process, tumbling process and cleaning
processes.
Prepare, coordinate, execute and evaluate Design of Experiment activities of
the Formulation and Fabrication Processes. Including polymer formulation,
lathing process, milling process, tumbling process and cleaning processes.
Maintain validation program up-to-date recommending, and performing
revalidation as required by process changes.
Maintain validation program in compliance with FDA and ISO 9000
Regulation
Oversee and assist in the implementation, maintenance and monitoring of the
DI water system, microbiological, chemical and pyrogen control programs.
Supplier and Vendor Audits
Exposure to FDA Audits, Form 483 and Warning Letter
Position: Manufacturer Engineer/Process Improver
Allergan Medical Optics - Medical Device
Period: 05/1995 to 06/1996
Task:
Raw Material and Product Investigation
Formulation, Molding and Extraction Processes Technical Support,
Troubleshooting and Improvements
Formulation, Molding and Extraction Processes and Raw Materials Design of
Experiment and Data Analysis
Documentation of Process to fulfill FDA and ISO 9000 requirements
University Working Experience:
Position: Process Support Engineer, Abbott Laboratories
Period: 1994
Task:
Reaction, Crystallization, Centrifuge and Drying Processes Optimization
Technical Support, Troubleshooting and Process Improvements
Mass Balance analysis
Processes Design of Experiment
Process improvements result in US$1 million annually saving
Position: Process Support Engineer, Westinghouse Electronic
Period: 1992 to 1993
Task:
Electroplating Processes and Wastewater Treatment Monitoring
Development of the Electroplating and Heat Treatment procedures to fulfill
ISO requirements
Key Words:
Computer System Validation (CSV)
Good Automated Manufacturing Practices (GAMP 5)
Annex 11 Computerized Systems EU
ASTM E2500 Standard Guide for Specification, Design and Verification of
Pharmaceutical and Biopharmaceutical Manufacturing System and
Equipment
International Conference on Harmonization (ICH)
ICH Q8 – Pharmaceutical Development
ICH Q9 – Quality Risk Management
ICH Q10 – Pharmaceutical Quality System
Job Hazard Analysis (JHA)
Hazard and Operability Study (HAZOP)
Failure Mode, Effect and Criticality Analysis (FMECA)
International Organization for Standardization (ISO)
ISO 9000 – Quality Management Systems
ISO 14000 – Environmental Management Standard
Skills:
Bilingual (English and Spanish)
Computer Proficient
Basic Sign Language
ISS Scuba Diving
Professional References:
Edwin Espinell Magdalena Ortiz
Engineering Director Project Lead Engineer
Abbott Laboratories Pfizer Pharmaceutical
787-***-**** 787-***-**** X 2637
*****.*.********@******.*** *********.*****@******.***
Ramon Navia Joseph Mall
Regional Manager BMS Remediation Manager
Foster Wheeler Oxford International
******@***.*** *****-*@*****.***
Personal and Professional References:
Victor Aviles Gerardo Gutierrez
Supply Chain Engineer IT Module Lead
Tres Monjitas CSC
******@*******.*** *************@*******.***
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