SUMMARY

• Over 14 years of work experience in the Engineering field in the Pharmaceutical/Biotechnology and Medical Device industry.
• Experience in Quality Assurance, GxP environment for validated/non - validated applications and Validation of regulated applications in accordance with FDA regulations.
• Managed large scale projects and multiple projects in parallel which included the management and monitoring of Project Budgets and Capital Expenses.
• Experienced in FDA regulations, including 21 CFR Part 11, Annex 11 and GxP guidelines.
• Focused experience on improving, engineering processes and reduction in manufacturing product unit costs.
• Experience in leading and managing teams of people which included but not limited to operators, technicians, maintenance personnel and Engineers.
• Experience in developing matrix reports and dashboards for Team meetings using: Microsoft Excel, Microsoft Project, and Primavera Software and Power Point presentations. Knowledge of Statistical software Minitab.
• Fully bilingual (Spanish and English) both written and spoken.
• Excellent team building skills.
• Skills handling and completing projects within the required and planned schedule, budget and with the utmost quality by always attending to stakeholder expectations.
• Skills handling procurements and identifying and mitigating risks.
• Knowledge of Photovoltaic Systems (Solar Panel Installations).
• Knowledge on electrical circuits and electrical components.
• Motors and motor installations and preventive and predictive maintenance.
• Transformers and how to combine the transformers (Delta, Star etc.), electromagnetic controllers, Programmable Logic Controllers (PLC), Auto Cad.
• Knowledge of the National Electrical Code (NEC)
• Experience with CMMS software such as MAXIMO, SAP and DataStream 7i (MP2).
• Experience with Failure Modes Effects Analysis (FMEA) Pro7 software.
• Participated in Certified Reliability Engineer (CRE) Training Program for the CRE Certification.
• Member of the National Science Foundation (NSF).
• Failure Modes Effects and Criticality Training (FMECA Training).
• Extensive Overall Equipment Effectiveness (OEE) Training.
• Experience in developing matrix reports and dashboards for Team meetings using: Microsoft Excel, Microsoft Project, and Primavera Software and Power Point presentations.
• Member of the IEEE Engineering Management Society (EMS)
• Experience and knowledge of GMPs and GDPs.
• Member of the Project Management Institute (PMI)
• Engineer in Training (EIT) license.
• Active member of the Puerto Rico Engineering and Land Surveyors Commonwealth Association (Colegio de Ingenieros y Agrimensores de Puerto Rico - CIAPR).

AREAS OF EXPERTISE

• Process & Equipment Validation (IQ OQ PQ)
• Packaging and Utility Equipment
• Computer System Validation (CSV)
• Cleaning Validation
• Reliability Engineering
• Continuous Improvement
• Failure Modes Effects and Criticality Analysis (FMECA) and Reliability Centered Maintenance (RCM)
• Materials Maintenance Management
• Work Order Planning
• Scheduling and Coordination
• Computerized Maintenance Management Systems (MAXIMO SAP and MP2)
• Preventive and Predictive Maintenance (Vibration Analysis, Infrared Technology)
• Key Performance Indicators (KPIs)
• 5S Technique
• Maintenance Best Practices
• Project Management Skills
• KAIZEN Teams
• Overall Equipment Effectiveness (OEE) Metric Implementation and Monitoring
• Tablet Compression Equipment such as Fette and Korsch
• Homogenizers (Micronization equipment)
• Coating Pans
• Granulation Equipment such as Glatt
• Tablet Printing Equipment
• Packaging Equipment such as Fillers
• Case Packers
• Labelers
• Cartoners (Bosch and Uhlmann Packaging Equipment).
• Boilers
• Cooling Towers
• Chillers
• Generators
• Compressed Air Equipment
• USP Water Systems
• Bio Reactors
• Autoclaves
• Environmental Stability Chambers
• RO Systems.

PROFESSIONAL EXPERIENCE

Confidential, Boulder, Colorado

Commissioning & Validation Engineer

Responsibilities:

• Validation protocols pre-requisites checks such as SOPs, Operating manuals and other equipment documentation.
• Development of validation protocols such as Installation (IQ) and Operational Qualification (OQ) protocols for Chrome Skids and Clean-In-Place (CIP) equipment.
• Performance of P&ID walkdowns and redlining of drawings.
• Verification of Major Components installations and correct tagging of components and labeling of piping.
• Verification of ISO drawings for slope verifications.
• Loop Check verifications.
• Pressure Test Verifications.
• Performance of Job Hazard Analysis (JHA).
• Working closely with Automation personnel for OQ testing on opening and closing of valves.
• Verification of Dead Legs and Drainage flow.
• Verification of Certificate of Compliance and Mechanical Completion of equipment installations.
• Verification of Turnover Packages (ETOP) and Vendor Turn Over Packages (VTOP).

Confidential, Louisville, Colorado

Commissioning & Validation Engineer

Responsibilities:

• Execution of Operational Qualification (OQ) protocol using Endotoxins.
• Performance of Temperature Mapping study on Autoclave equipment utilizing E-Lab software and thermocouples.
• Development of Deviation Reports and working closely with the Quality Assurance dept. on the resolution of the deviations and Root Cause Investigations for re-execution of identified deviations resulting from OQ testing.
• Validation of Cryo-Freezers.

Confidential

Validation Engineer

Responsibilities:

• Developing validation protocols including IQ and OQ.
• Components verifications of main production equipment including Reactors and Raw Material Charging System.
• Component verification of Compressed Air System.
• Working with Mechanical contractors.
• Performed Walk downs of Compressed Air System and Manufacturing Equipment and components.
• Identification of components and Redlining Process and Instrumentation diagrams (P&IDs).
• Developed Temperature Mapping Qualification protocol and Reports for offsite Raw Material Warehouse.
• Identification of Spare Parts for compressed Air system and Reactors.
• Identifying missing TAGs of components.
• Identifying Instruments and their instrument Information Forms (IIFs) and Calibration Certificates and Calibration IDs.
• Developed Cleaning Validation protocols for manufacturing equipment used for Granulation and Coating of tablets describing residue limits, cleaning parameters (TACT - time, action, cleaning chemistry and temperature).
• Knowledge and experience with swab and rinse cleaning sampling methods.
• Use of swabbing method for cleaning validation of tablet compression equipment which included swabbing pattern to follow, surface area to be swabbed, number of swabs etc.
• Performed assessment on direct impact utility systems specifically USP used for cleaning equipment to make sure they were properly qualified before CIP process.
• Evaluated solvents used for rinsing equipment.
• Developed and worked closely with the Quality Unit regarding validation interim reports for manufacturing equipment and rooms cleaning activities including summary of the activities, analytical test results and list of all discrepancies and resolutions.
• Experience with Cleaning Validations and SOPs in determining and identifying Critical Performance Parameters (CPPs) such as: process times (including Dirty-hold) and cleaning agent concentration. Also Critical Quality Attributes such as visual Inspection, microbial (Bioburden/Endotoxin) and conductivity/pH.
• Performed statistical experiments and analysis using Minitab to reduce manual cleaning process variations related to variables such as different operators, different physical strengths and day shift, 2ndshift, 3rdshift, weekend differences and others.

Confidential, Puerto Rico

Computer System (CSV) and Process Validation (PV) Engineer

Responsibilities:

• Develop and execute Test Cases for IQ, OQ and PQ.
• Develop Traceability Matrix.
• Performed Process Characterization Studies with Design of Experiments to determine best values to enter in equipment settings to obtain quality outputs (Essential Design Outputs).
• Experimental Trial Runs as part of Characterization study.
• Worked with Source Code Reviews (SCR)
• Developed Validation Change Management and System Requirements Specifications (SRS)
• Knowledge of ISO 13485
• Knowledge of CFR Part 820
• Development of Traceability Matrix. Identifying System Requirement Specifications with IQ/OQ Test Cases (Element Numbers)
• Process Characterizations to determine processing parameters such as speed, temperature.
• Developing Design Specifications for System/Software Operations
• Executed Test Cases included in Computerized Systems Installation and Operational Verification (CSIOV) such as: Hardware Components Verification, Hardware Configuration Verification, Software Components Verification, Discrete Inputs and Outputs Verification, Analog Inputs and Outputs Verification, Drawings Verification, 21 CFR PART 11 Coverage Assessment Verification and Documentation and Manuals Verification.
• Developed Final Summary Reports of the Commissioning Activities Performed and activities and results of IQ, OQ and PQ Test Cases including any deviations identified and their resolution
• Documented, coordinated and addressed the resolution of deviations and deficiencies
• Developed Commissioning Test Plans.
• Perform Test Cases for Installation and Operational Verification (IQ/OQ)
• Installation Qualification:
• Wiring and Cabling Verification
• Hardware Components Verification
• Hardware Configuration Verification
• Software Components Verification
• Discrete Inputs and Outputs Verification
• Analog Inputs and Outputs Verification
• Drawings Verification
• 21 CFR PART 11 Coverage Assessment Verification
• Documentation and Manuals Verification
• Operational Qualification:
• Screen Navigation Verification
• Logical Security and Access Verification
• Boundary Conditions (Ranges) and Field Verification
• Emergency Stop Sequence Verification
• Stress Test (Maximum Number of Users/Applications, etc.)
• Audit Trail Verification
• System Startup, Shutdown and Power Loss Test
• Communication Failure and Recovery Verification
• Faults and Alarms Verification
• System Time/Date Verification
• Functionality Verification
• Reports/Graphics Generation Test
• Software Backup Master Copy Verification

Confidential, Puerto Rico

Validation Engineer/Consultant

Responsibilities:

• Developed Interim Reports to summarize results of protocol Test Cases.
• Developed Final Summary Reports of the Commissioning Activities Performed and activities and results of IQ, OQ and PQ Test Cases including any deviations identified and their resolution.
• Experience with plant Security System Components Test Cases and Building Management Systems (BMS).
• Experience with the following in relation to commissioning and validation:
• Compressed Air Test Forms
• Fire Protection system Verifications
• Illumination Verification Tests (Room Layout with Grid references using a light meter).
• Equipment Troubleshooting for Research & Development participation for purposes of developing new drugs.
• HVAC and Environmental Conditions Verification (Chart Recorders).
• Developed Discrepancy Reports (Discrepancy’s which were identified and had to be documented and resolved) during the performance of the test forms and test cases included in the validation protocols.
• Preparation of Attachment Log List (All Attachments included in the protocol as supporting evidence for the commissioning activities).
• Participated in the development of User Requirement Specification (URS) Documents regarding equipment to be purchased to be used in a new facility for Research & Development (R&D) purposes.
• Validation of Equipment which was used for R&D purposes.
• Incorporated into the URS document the function to be carried out, the data to be used by the equipment and the operating environment were equipment was going to be used.

Confidential, Puerto Rico

Engineering Compliance Specialist

Responsibilities:

• Developed Remediation Plans for Equipment for Verification purposes during a Consent Decree.
• Gathered equipment qualification evidence to develop Remediation Plans during a Consent Decree situation in the pharmaceutical company.
• Developed Summary Documents to compile equipment Remediation Plans.
• Participation of Management Review meetings with third party consultants to review and discuss FDA regulations and requirements to identify progress of Remediation actions.
• Hands-on experience with test/measurement equipment, such as voltmeters, temperature probes, oscilloscopes and power supplies.

Confidential, Puerto Rico

Validation Engineer/Consultant

Responsibilities:

• Developed Validation Protocols (Installation and Operational Qualification) for the validation of equipment such as Tablet Press, Capsule Filling Machine and Hi Coater (Coating Pan) Machine.
• Participated in project team meetings to review status of projects.
• Developed protocols for the packing and transportation of laboratory equipment and included these in SOP.
• Performed Computer System Validation following GAMP 5 rules and regulations.
• Performed Computer System Validation (CSV) and complete System Development Life Cycle (SDLC).
• Executed Validation Protocols (Installation and Operational Qualification) for the validation of equipment such as Tablet Press, Capsule Filling Machine and Hi Coater (Coating Pan) Machine which included Test Cases such as Instrument Calibration Forms, Electrical Tests, Environmental Health & Safety, Preventive Maintenance, Spare Parts and Utilities Test Case.
• Developed and Executed Protocol for the Validation and Commissioning of Facilities and Utilities of a Pilot Plant used for Research & Development Purposes.

Confidential, Puerto Rico

SAP Master Data Analyst

Responsibilities:

• Validation of SAP Plant Maintenance Modules and SAP Plant Maintenance business test scripts.
• Development and Execution of Business Process Testing (BPT) and Validations for the SAP Plant Maintenance Module Transactions
• Preparation and Development of SAP Plant Maintenance Standard Operating Procedures (SOPs).
• Assisting in a Consent Decree process in relation to the CMMS (SAP Plant Maintenance).
• Developing and Executing SAP Plant Maintenance Validation Protocols (Installation Qualification - IQ, Operation Qualification - OQ and Performance Qualification - PQ).
• Verifying instrument and equipment details and information against the SAP Plant Maintenance System.

Confidential, Puerto Rico

Validation Engineer Consultant

Responsibilities:

• Validated manufacturing equipment and developed and wrote Validation Master Plans (VMP).
• Performed Computerized System Validation (CSV) according to GAMP 5 FDA criteria.
• Developed and executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for CSV and non CSV equipment.
• Developed CSV Installation Qualification (IQ) and Performance Qualification (PQ) documentation related to a Crimper machine/equipment which was going to be relocated from one product assembly room to another product assembly room due to a Lean Manufacturing Re-Layout initiative. All Change Control documentation was originated and developed according to FDA GAMP 5 procedural formats.
• Developed Design specifications which were included in the URS of new equipment.
• Conducted feasibility studies for design controls of medical device.
• Developed Factory Acceptance Test (FAT).
• Incorporated IQ, OQ, and PQ tests into a FAT document in order to challenge parameters and equipment functions identified by the vendor for new equipment to be used for experimental purposes.
• Developed with others Commissioning Test Plans for Compressed Air, Purified Water and HVAC verification.
• Experience working and developing Traceability Matrices.
• Gathered all relevant data such as electrical, spare parts, PLC and calibration specifications and parameters to execute IQ, PQ and OQ.
• Performed Validations according to GAMP 5 and companywide validation procedures.
• Participated in the development of the Validation Master plan related to an equipment Lean Manufacturing Re-Layout project. The Validation Master Plan included all equipment requiring re-validation, the justification and criteria to re-validate and also the criteria to perform Installation Qualification (IQ), Operational Qualification (OQ) and/or Performance Qualification (PQ) based on GAMP 5 requirements. This Validation Master Plan also included CSV equipment and the criteria used to classify equipment as CSV.
• Originated, wrote and developed change controls forms related to equipment.
• Executed with a team of plant engineers, system owners, key end users and quality personnel Risk Assessmentexercise (FMECA) to identify potential compliance risks associated with equipment systemand processes and identified the strategies that will be used to mitigate the risks based on severity, occurrence and detection of possible failures.
• Identified elements to evaluate in Risk Assessment exercise in relation to changes identified and included in Change Control mechanisms to determine if revalidation of the system and equipment needed to be performed. Mostly in terms of Computer System Validation based on GAMP 5 criteria.
• Made sure the medical devices were in compliance with quality system requirements, Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements and Quality System Regulation, 21 CFR Part 820.