Project Manager Quality Assurance

Sr. Validation Professional/Validation Manager

Sr. Validation Engineer/Sr. Principal Q.A. Engineer

Project/Process Engineering, Installation, Commissioning, Start-Up, Qualification, Process Validation, Process Optimization, Technology Transfer, Quality Assurance and Regulatory & Compliance

Accomplishments driven professional with over 25 years of experience in the Pharmaceutical and Biotechnology industry with last 15 years in comprehensive small and large scale management and pharmaceutical engineering experience in diversified projects. Strong background in program development and quality assurance with outstanding history of managing projects from initial conception, through development, to implementation. Unexcelled record of bringing mission-critical projects in on schedule and within budget. Especially skilled at strategic planning, budget controls and daily problem/issues troubleshooting/resolution with sensible achievable in time/budget solutions. Outstanding communication talents with proven ability to build and lead highly efficient teams, to train technical personnel, and to convey complex concepts in understandable terms. Strong background in Quality Assurance compliance, agency inspections. Investigations, Product presentation, CAPA and Change Control.

Areas of Expertise

Project Lifecycle Management

FDA, ICH, USP, WHO, EMEA, ISO, Mexico SSA and Latin American Countries Health Regulations Pharmaceutical/Biotech Processes

Aseptic Processes/Batch Records

Gap Analysis, Process Optimization

Troubleshooting

Operational Excellence Validation Programs, Validation Master Plans

ISPE Guidelines

Engineering Documentation/RFI, Cost Reduction / Budget Controls & Capital Appropriation Request

Contractor, Supplier, Procurement Cost Reduction / Budget Controls & Capital Appropriation Request Parenterals, Injectables (Liquid

& Freeze Dry) Media Fills

Solid Oral, Liquids, Cream & Ointments

(Sterile/Non-Sterile)

Bulk Chemicals / API’s

DEA Controlled Dosages (CI-CV)

Packaging, Manufacturing Operations SOP’s, Change Control, KT, CAPA, Regulatory & Compliance, QSR’s, Quality Assurance Standards, 21CFR210/211/Part 11

Clean Utilities

GMP Facilities/Utilities. Engineering Drawings, Design Revision Risk Assessment, FMEA. Statistical Analysis Temperature Mapping, MKT’s

Team Recruiting/Staffing, Training & Mentoring

Electronic Batch Records/Signature Clean Room Certification

User requirements, Functional Specifications/Sequence of Operations

Systems Integration or Migration Technology Transfer, FAT, SAT, Technical Assessments, Process Development, Evaluation/Refinement

CSV (DQ, FRS, URS, DDS, AIQ, AOQ &APQ)

DCS, BMS, BAS, LIMS, Maximo, Trackwise, SCADA, Empower, Quality Stream & SharePoint SIP, CIP, Validator 2000, Sterilization /Depyrogenation, Environmental Monitoring/Smoke Studies C&Q&PV (DQ, Commissioning, IQ, OQ & PQ) Cleaning/Process Validation

Career Progression

Stryker Instruments; (3 month contract Aug to November 2010). Currently, available immediately.

Kalamazoo, Michigan

Advanced Manufacturing Engineer

Advanced Manufacturing Engineering

Research & Development

Sub Contracted by: Oxford Global Resources, Inc.

Validation Consultant for the Advanced Manufacturing Engineering Research & Development Area.

In charge of the development of the Manual Qualification processes for the new S7 Handpieces (surgical drills and saws), OQ-P and PPQ documentation. Facilitator/Coordinator of the execution of these studies.

Performance of all DOE’s and ENG studies.

Reviewer of all team documentation and process SOP’s.

Reviewer of all the validation documents and daily validation issues.

Covidien Aug 2009 – Aug 2010

Hobart, NY

Principal Q.A. Engineer

Liquid and Solid Dosage (CI to CV) Qualification supervisor/facilitator/coordinator/troubleshooter.

Qualification & Validations Program and Plans Designer, SOP’s development and training. Supervision of Validation engineers, Specialist and Analysts. Supervision and mentoring of all projects personnel assigned.

Computer System Validation, Site Validation Master Plan, Project Lead for Document Management and Change Control Systems Electronic Migration (from paper to electronic files) and Implementation.

Regulating Agencies Inspections, QSR’s, and Investigations, Exceptions, Deviations/CAPA, and Regulatory & Compliance issues.

Product Annual Review, Manufacturing Instructions, Batch Records, Production Operations and Validation Documentation Audit and daily Troubleshooting.

FMEA, KT, Exception, Risk Assessment, Gap Analysis and other investigative techniques.

Engineering Studies for different equivalency of packaging components and equipment with QIP projects saving over $150,000.00 in less than 8 months of employment.

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Sub Contracted by: Validation Technologies, Inc. Dec 2008 – May 2009

Biogen, Boston and Amylin, Ohio

Sr. Validation Engineer

Facilities, Utilities, Plant Start-up/Commissioning& Qualification facilitator/coordinator. Supervision of various commissioning/qualification contractors and consultants for ETOP packages delivery.

Manage Qualification & Validations, SOP’s development and training.

Aseptic Processes (Aseptic Fill, Media Fills, Sterilization/Depyrogenation, Isolators, VHP; Autoclaves, Ovens, Tunnel Validations, CIP/SIP, Water Systems, Gases, Automated Systems; BAS and SCADA). Computer System Validation (SDLC), Change Control.

QSR’s, Investigations/CAPA. Regulatory & Compliance

PAI Engineering/Validation and QA Consultant.

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Sr. Regulatory & Compliance, Engineering & Validation Consultant

Consulting services for Validation Processes managing various Pharmaceutical and Biotech plants. Compliance and Validation Contractors for different projects in Puerto Rico

SOP development and training.

Food Industry Compliance consultant.

Change Control, CAPA, FDA, ICH, EMEA, WHO & ISO Compliance and QA Regulatory Documentation.

Automated Warehouse managing systems. CSV Programs. Building Automated Systems Integration and Qualification.

Automated packaging systems. Minimized validation costs to clients by 30% on all projects assigned.

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Sub Contracted by: ISS Corp.

Bristol –Myers Squibb Holdings Pharma, LTD Liability Company, Jan 2006-Oct-2008

Manati, Puerto Rico

Validation Manager and Sr. Regulatory & Compliance Consultant

Managed Master Validation Plan for the GMP Work Plan Protocol #6 (Corporate)

Development, Management and Implementation of the Facilities, Utilities and Validation Systems Remediation Plan. Managed all aseptic validations (SIP, CIP, Autoclaves, Ovens and Tunnels). Isolators’ technology for total automated aseptic manufacturing processes. VHP, product fill, freeze dry automated loading/unloading and packaging.

Supervision of 10 professionals. Automated Systems and Computer Systems Validation.

Assisted top management on daily troubleshooting and presented sensible solutions to complex situations.

In charge of all capital appropriation requests and support to Parenteral, Lyophilization and Oral Solid Dosage manufacturing departments.

QSR’s, Investigations/CAPA. Regulatory & Compliance

Deviations, Exceptions, CAPA, Change Control, FDA, EMEA & ISO Inspections for Compliance and QA Regulatory Documentation.

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Sub Contracted by: Fluor Daniel

Abbott Biotechnology Limited Jan 2005-Feb 2006

Barceloneta, Puerto Rico

Project Validation Manager/Team Facilitator

ABBOTT

Manage all teams (12 teams three persons each) performing Facilities, Utilities, Process Equipment Commissioning, Qualifications and Validations. Managed the Qualification of the Facilities and Suites certification (per room classifications) reporting to Abbott Vice president of engineering.

On Time and within budget Fast Track Turn-Key project.

Design, preparation, presentation and update of Project schedules based on client manufacturing requirements dates.

Team & Project Progress curves analysis for consulting assurance and cost variances.

Supervision of Client (Abbott) microbiology laboratory team of 15 professionals performing room suites (support) to the room PQ teams. Schedule, testing, shifts documentation evaluation/approval, quality assurance/regulatory & compliance audit for agencies inspections and logistics.

GLAXO SMITH KLINE

• Managed 10 professional during the Consent decree performing room classification studies, viable and non-viable particulate studies to produce recommendation and implementation of the recommendations as well as the required qualification/validation studies.

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Merck Sharp & Dohme May 1995-Oct 1999/ Dec 2002-Dec 2004

Barceloneta, Arecibo, Puerto Rico and México

Projects Validation Manager / Project Facilitator

Provision of consulting services assisting the resident engineer to troubleshoot and determine sensible solutions within compliance of specification and corporate requirements to different complex projects under the capital projects department for all MSD Plants in Puerto Rico. New Plant Expansions for several products as PRILOSEC, MEVACOR, ZOCOR Plant Process Equipment Improvement, Facilities and Utilities, Technical Operations Laboratory Renovation, Quality Operation Laboratory Improvements, and all Manufacturing Areas.

Perform all the required investigations for deviations; provide technical explanations for variance and CAPA events.

Submit recommendations for daily situations concerning to GMP issues.

Validation of all mechanical and automated systems for aseptic and solid oral dosage processes

• Facilities, HVAC, HEPA Filter Certification, and Depyrogenation Ovens, Formulations, Granulator, Extruders, Blenders, Coaters, Tooling, Parts Washers, Filling Machine, Tote Washer, WFI System. USP, Clean Steam, SIP, CIP, Autoclaves, Compressed Air, Gases, R.O., Chilled Water

• Welding certifications, piping cleaning & passivation

• SOP development, revisions and training

• Change Control QSR’s, Agency presentations.

• Regulatory & Compliance

1999 – 2003 Project/Validation Manager for installation, commissioning, qualification and process validations of the new facilities, utilities, warehouse, computerized systems, manufacturing and packaging processes of the Merck’s México Modernization Project Phase 1 and 2 (New Aseptic Filling, Solid Oral Dosages, Packaging, New QA laboratories and New Automated Warehouse). Validation manager, facilitator and coordinator for the entire design built project, as well as Merck’s liaison officer with the construction contractors, A&E, Plant engineering, and subcontractors. Managed all the technology transfer for the new manufacturing areas. Supervised 30+ personnel and over $10MM budget. Managed the PAI for Mexico Health Department (SSA) and WHO.

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Sub Contracted by: Day & Zimmerman Corp. Jan 2002-Dec 2002

Schering-Plough Products, LLC

Manati, Puerto Rico

Project Manager/Validation Manager/Project Facilitator

• Project Manager for the Renovation of the Aseptic Facilities Project

• Consent Decree Consultant

• Supervision of team leaders of Mechanical & Automated systems qualifications

• Supervision of 20 engineering and validation professionals

• Validation documentation, deviations/CAPA, variance and GMP SOP’s SME

• Consent decree Steering Team member

• Supervision of field activities, scheduling and liaison with contractors, suppliers and partners

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Ocular Sciences International 1995

Santa Isabel, Puerto Rico

Project Engineer/Validation Engineer/Project Facilitator

• Consultant for Ocular Sciences International Plants & Suppliers

• Developed an efficient contact lenses injection molding manufacturing processes

• Developed a static free demolding process

• Developed a higher yield hydration process

• Maximized plant space use, energy conservation

• Achieved higher production yields and quality

• Performed investigation studies to determine cause of failure on lens tinting process and developed a new validated process

• Executed Cross Functional studies on injection molding process to determine causes of processes deficiencies

• QA inspections, Manufacturing process improvements

• Technical Services/Validation/Regulatory Affairs Consultant

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Sub Contracted by: Caribbean Industrial Construction Inc. 1995

Faulding, Aguadilla, Puerto Rico

Validation Manager

Project: Shell Glass Vial Aseptic Manufacturing Facilities Remodeling & Relocation

• Validation Manager/Facilitator for CIC, Inc.

• Design-Built Project A&E and Construction Contractor liaison with client engineering department

• Manage Commissioning/Validation

• Facilities qualifications

• Vault qualification for storage of DEA controlled finished products and raw materials.

• Validation Master Plan, protocol generation, revision and approvals. Final reports

• Facilities, HVAC, HEPA Filter Certification, and Depyrogenation Ovens, Vial Washers/Siliconizer, Filling Machine, Parts Washer, WFI System. USP, Clean Steam, SIP, CIP, Autoclaves, Compressed Air, R.O., Chilled Water. Welding certifications, piping cleaning & Passivation. SOP development, revisions and training

• Change Control, Regulatory & Compliance

Global Industry Integrated Services

Arecibo, Puerto Rico

Owner/President

Syntex

Humacao, Puerto Rico May 1993 – May-1994

Project: New Naproxen Computer Controlled Manufacturing Plant

• Validation Lead (Supervised 10 professionals)

• Facilities and Utilities Commissioning, Qualification & Process Validation

• Validation of the PAM (Process Area Manager)

• Process validation of computerized controlled manufacturing systems: Warehouse in-process, material testing (from sampling to approval) to distribution throughout plant with AGV’s (automated guided vehicles), formulation, granulation, blending, compression, coating, packaging, to warehouse storage.

• In charge of the development, execution, revision and analysis of all the data corresponding to all the commissioning, qualification and validation projects of the entire project which included all the disciplines of the entire manufacturing solid dosage plant.

• Automated CIP, PLC’s, BAS, SCADA and LIMS communicating to PAM.

• Protocol development, data gathering and reports for this entire project (Facilities, HVAC, HEPA, and Clean Steam, Autoclaves, Compressed Air, R.O. system, Welding certifications, passivation and Chilled Water Systems.

• SOP’s, Change Control, QA and daily troubleshooting.

EDUCATION

B.S. in Sciences (Chemistry) – June 1984

Four (4) years of Chemical Engineering

Colegio Mayagüez, Mayagüez Puerto Rico

Associate Degree; Metrology & Instrumentation - June 1991

Puerto Rico Government Issued

ADDITIONAL EXPERIENCE

Wyeth Mexico (2003), Plant Process Equipment Improvement, Facilities and Utilities, Manufacturing and Warehouse area Expansion Project Manager. MOVA Pharmaceuticals and Eli Lilly expansion projects in 1994 (Puerto Rico). 1994 to 1996 seven different projects in seven different Pharmaceutical companies in Puerto Rico, Latin America: Colombia (Merck & Co.), Brazil (Biobras), Costa Rica (Medigray) and the USA (Merck Elkton, VA). US Army (Military Intelligence) Veteran.

• Employee at Schering-Plough (Manatí) (1987-1993); Senior Validation Specialist/Supervisor of validation projects for all site sterile and non-sterile processes, including: cream, ointments, liquids, fermentation, steroids, antibiotics and chemical plants.

• Employee at Bristol-Myers (Mayagüez) (1984-1987); Validation Specialist in charge of all the aseptic process validations and lyophilization.

• Hydrologist with the US Geological Survey (1983-1984). Surface and underground water studies.

• As a pharmaceutical/biotechnology consultant have worked over 50 projects in58 different sites.

References Available Upon Request

Additional Expertise & Trainings

• FDA, DEA, ICH, WHO, ISPE, ISO, EMEA, EU, GxP’s, Standards, Guidelines & Regulations.

• Technical writing and CAPA investigations.

• Well experienced when dealing with regulatory agencies.

• Knowledge on the current automation, control and communications software.

• Current in all Microsoft software’s.

• Seasoned as project facilitator and daily troubleshooting.

• Knowledge of all current Microsoft software’s, as well as ACAD.

• Experienced on design verification/qualification.

• Expert on project controls, scheduling and execution efficiency.

• Validation troubleshooting, documentation development, execution, data analysis, evaluation, reporting and approvals processes.

• SME on Management of Change Controls, Design Qualifications, Equipment, Utilities & Facilities Qualification Process, Packaging processes qualification/validation and QA Compliance.

• Certification Module for Commissioning, Validation and Qualifications Programs.

• SME Validation Master Plans, Capital Projects and Projects Walk Down with Punch List Guides and Risk Assessments (Analysis), GAP Analysis for 21 CFR 210/211, Part 11.

• Preparation and Execution of an Installation Completion Record (ICR).

• Business Process Guidelines and Qualifications for Capital Projects.

• Good Manufacturing Process (GMP) Security, Safety & Environmental Regulations. Manufacturing processes and logistics

• Preparation, Execution and Closeout of Commissioning & Validation Protocols.

• Equipment Modification Procedures and Early Technical Assessment Management.

• Risk Management & Risk Assessment, FMEA and KT for all stages of projects and processes.

• Good Engineering Processes (GEP) / Purchasing in Capital Project Guide.

• SME GMP Documentation, Validation Requirements, Regulations & Compliance, Procedures (SOP’s) and Validation/ QA/Technical Services Management. Quality Assurance Engineering,

• BAS, BMS, DCS and Automation & Software Validation.

• Consent Decree Consultant

• Expert on Utilities: HVAC, Steam Systems, Sterilization/Depyrogenation Systems, Pre-Treatment and Pure Water Systems & Gases.

• Aseptic Process: Small volume parenterals & large volume parenterals/liquid and injectables, biotechnology processes. Liquids, Cream & Ointments and Oral Solid manufacturing processes. Generics/Bioequivalent.

• Oral Solid Dosages (Solid and Liquid) processes.

• LIMS, Empower, Quality Stream, Share Point, Trackwise, COSMOS, etc., SCADA, PLC, and many other automation technologies validation.

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