ALEX RAMOS

**** **** ********** *****  Bloomington, Indiana 47401

Cell Phone: 812-***-****  Email: ex392u@r.postjobfree.com

COMPUTER SYSTEMS VALIDATION ENGINEER

Biotechnology  Pharmaceutical  Medical Device  Chemical Plant

Computer Systems Validation Engineer with wide-ranging experience in Biotechnology, Pharmaceutical, Medical Device and Chemical Plant (API) environments. Background in start-ups and on-going operations. Expertise includes Validation in Computer and Software, Equipment, Chemical and Finished Product Processes, Utilities and Facilities. Fully bilingual (English/Spanish) and seeking full-time work.

 Software Development Life Cycle (SDLC) Methodologies  Protocols Development  Execution Documentation Compliance  Standard Operating Procedures  Internal Audits and Remediation Plans  Change Control  Validation Project Leader  CAPA  Customer Complaints  Temperature Mapping  Annual Stability Lot Reports  QA Engineer  LIMS  21 CFR Part 11 Regulations for Computer Systems Validation  FMEA  Delta V DCS  Allen-Bradley PLC

SKILLS & CAPABILITIES

Validation Program Development/Implementation

• Developed and implemented the Computer Systems Validation Program; reduced time in the review and approval process for the automation and software change controls for Cook Pharmica Biotechnology.

• Performed the remediation and retirement activities for medical devices as part of the Legacy Software Remediation Project for Boston Scientific.

• Prepared and executed validation activities for equipment and utilities such as biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers and refrigerators for the start-up facility; actively involved in the implementation of the Labware Laboratory Information Management System (LIMS) Project for Cook Pharmica Biotechnology.

• Participated in the implementation of the Delta V Distributed Control System (DCS) Corporate Project for Eli Lilly.

• Created and executed Commissioning, Installation Qualification (IQ) and Operational Qualification (OQ) Protocols for Allen-Bradley PLC for Process Tanks and Filler Machine for Schering Plough.

• Generated and executed validation/qualification protocols (IQ, OQ and PQ) for process tanks, compressed air system, quality control laboratories and HVAC system for Ortho Biologics.

Quality Assurance & Compliance

• Reviewed and approved documents such as validation and project plans, validation protocols, validation summary reports, standard operating procedures (SOPs), manufacturing specifications, manufacturing and packaging batch records for Schering Plough.

• Performed investigation reports for medical/non-medical customer complaints from the QA standpoint.

• Reviewed and approved Computer Validation Protocols for Manufacturing/Packaging (Fluid Bed Dryers, Filler Machines, Tablet Press Machines, Autoclaves, Checkweighers and V-Blenders) and Laboratory (FTIR, GC, HPLC and TOC) Systems for Wyeth Pharmaceuticals.

• Reviewed and approved Computer System Validation documentation for non-chromatography laboratory systems; reduced time in the documentation review and approval process for Bristol-Myers Squibb Manufacturing.

Technical Documentation

• Technical professional with superior project management skills; able to work under pressure; customer service oriented, excellent writing, communication and negotiation skills. Experience work in a consent decree environment.

• Created the Software Development Life Cycle documentation such as validation plan, user requirement specifications, functional requirement specifications, change control, design specifications, testing, traceability matrix and system acceptance report for laboratory systems (GC, HPLC, TOC, FTIR, and Spectrophotometer) for Eli Lilly.

Leadership, Team Work

• Supervised 5 Validation Specialists and 3 Consultants during the implementation of all Bristol-Myers Squibb projects; resolved project issues, attended project meetings, reviewed validation documents, trained consultants and employees, approved timesheets, generated project proposals, and coordinated validation activities.

PROFESSIONAL EXPERIENCE

BOSTON SCIENTIFIC CORPORATION Spencer, Indiana 2009 to Present

Software Validation Engineer

COOK PHARMICA BIOTECHNOLOGY Bloomington, Indiana 2007 to 2009

Computer Systems Validation Associate

Cook Pharmica is a contract manufacturer of biopharmaceutical products for both clinical and commercial use from cell line development through packaged drug product.

VALIDATION CONTRACTOR 1998 to 2007

WYETH PHARMACEUTICALS COMPANY

QA Validation Consultant (4 months)

PFIZER GLOBAL MANUFACTURING

Validation Consultant (8 months)

CORDIS (JOHNSON & JOHNSON MEDICAL DEVICE)

Validation Consultant (1 Year)

BRISTOL-MYERS SQUIBB MANUFACTURING

Validation Project Leader (2 years, 1 month)

SCHERING PLOUGH PRODUCTS

Senior Computer Validation Specialist (1 Year)

ELI LILLY AND COMPANY

Computer Systems Validation Engineer (2 years, 1 month)

ORTHO BIOLOGICS (JOHNSON & JOHNSON BIOTECH)

Validation Engineer (9 months)

SCHERING PLOUGH PRODUCTS

Quality Assurance (QA) Engineer (1 Year, 7 Months)

Validation Specialist

PROFESSIONAL EDUCATION

University of Puerto Rico BS, Chemical Engineering

PROFESSIONAL DEVELOPMENT & SPECIALIZED TRAINING

 GXP & FDA Regulations

 21 CFR Part 11 Electronic Records/Electronic Signatures

 Good Automated Manufacturing Practices (GAMPs)

 Computer Systems Validation sponsored by the Institute of Validation Technology (IVT)

 21 CFR Parts 210 and 211

 21 CFR Part 820 (Quality System Regulations)

 Delta V DCS Training

 Kaye Validator 2000 and Kaye Valprobe Loggers

 Laboratory Information Management System (LIMS) Fundamentals Training

 Data Compliance System (DaCS) Administrator Training

 Problem Solving

 FMEA Workshop

 Validation Sampling Plans

PROJECT LIST

BOSTON SCIENTIFIC CORPORATION - Software Validation Engineer

• Developing and executing the Remediation and Retirement deliverables for medical devices as part of the Legacy Software Remediation Project.

COOK PHARMICA BIOTECHNOLOGY- Computer Systems Validation Associate

• Developed and implemented the Computer Systems Validation Program.

• Performed Periodic Reviews for SAP/ERP and Electronic Document Management System.

• Reduced time in the review and approval process for the automation and software change controls.

• Prepared and executed validation activities for Equipment and Utilities such as Biosafety Cabinets, Gases, Laboratory Systems, Incubators, Stability Chambers, Freezers and Refrigerators for the start-up facility.

• Actively involved in the implementation of the Labware Laboratory Information Management System (LIMS) Project.

• Technical support to the Engineering and QA groups; including redline and system drawings revision, Turnover Packages (TOPs) revision and completion.

• Develop Validation Documents such as Impact Assessment, User Requirements Specification, Risk Assessment, Design Review, Commissioning Protocols, IQ/OQ Protocols and Validation Summary Reports.

WYETH PHARMACEUTICALS COMPANY - QA Validation Consultant

• Reviewed and approved Computer Validation Protocols for Manufacturing/Packaging (Fluid Bed Dryers, Filler Machines, Tablet Press Machines, Autoclaves, Checkweighers and V-Blenders) and Laboratory (FTIR, GC, HPLC and TOC) Systems.

PFIZER GLOBAL MANUFACTURING - Validation Consultant

• Worked in a Decommissioning Project.

• Retired, destroyed or archived Validation Protocols, SOP’s, Guidelines, Policies, Client/Servers and Application Software based on Pfizer’s Retention Requirement Standard Operating Procedure.

• Created System Retirement Plan, Data Migration Verification, Data Management Report and Final Retirement Report for Electronic Systems such as Calibration Manager, LIMS, Foxboro, CAPA, Chromatography Data System, Manufacturing Data, Training Management and Series Batch Assignment.

CORDIS (JOHNSON & JOHNSON MEDICAL DEVICE) - Validation Consultant

• Generated and executed Clean in Place (CIP) and Washing in Place (WIP) Control System Validation Protocols.

• Generated and executed Validation Documentation (Validation Plan, URS, FMEA, Design Validation, Protocols and Final Reports) for Binder Vacuum Ovens and Vacuum Pumps.

• Generated and executed Validation Protocols for Glassware Washer, Depyrogenation Oven and Water System.

BRISTOL-MYERS SQUIBB MANUFACTURING - Validation Project Leader

• Supervised 5 Validation Specialists and 3 Consultants during the implementation of all Bristol-Myers Squibb Projects.

• Resolved project issues, attended project meetings, reviewed validation documents, trained consultants and employees, approved timesheets, generated project proposals, and coordinated validation activities.

• Worked in the GMP Work Plan Corporate Project for Cleaning, Test Method, Process, Laboratory, and Computer Validations.

• Reduced time in the documentation review and approval process.

• Reviewed and approved Computer System Validation Documentation for the Non Chromatography Laboratory Systems.

• Reviewed Drawings (HVAC Flow Diagrams, Water Systems, Utilities and Buildings Layouts) against the field.

• Verified Manufacturing, QA and Laboratory Procedures against the Worldwide Bristol-Myers Squibb Guidelines and Policies.

SCHERING PLOUGH PRODUCTS - Senior Computer Validation Specialist

• Worked on a Consent Decree environment.

• Created and executed Commissioning, Installation Qualification (IQ) and Operational Qualification (OQ) Protocols for Allen-Bradley PLC for Process Tanks.

• Performed 21 CFR Part 11 Electronic Record/Electronic Signature Assessments to Packaging Systems such as Unscrambler, Filler, Capper, Labeler and Cartoner.

• Created and executed Installation Qualification (IQ) and Operational Qualification (OQ) Protocols for Allen-Bradley PLC f Filler Machine.

ELI LILLY AND COMPANY - Computer Systems Validation Engineer

• Created the Software Development Life Cycle documentation such as Validation Plan, User Requirement Specifications, Functional Requirement Specifications, Change Control, Design Specifications, Testing, Traceability Matrix and System Acceptance Report for Laboratory Systems (GC, HPLC, TOC, FTIR, and Spectrophotometer).

• Generated Backup & Restore and Logical Security Procedures for Laboratory Systems.

• Generated and executed Installation Qualification (IQ) and Operational Qualification (OQ) Protocols for Single Loop Controllers.

• Participated in the implementation of the Delta V Distributed Control System (DCS) Corporate Project.

ORTHO BIOLOGICS (JOHNSON & JOHNSON BIOTECH) - Validation Engineer

• Generated and executed Validation/Qualification Protocols (IQ, OQ and PQ) for Process Tanks, Compressed Air System, Quality Control Laboratories and HVAC System.

SCHERING PLOUGH PRODUCTS - Quality Assurance (QA) Engineer/Validation Specialist

• Reviewed and approved documents such as Validation and Project Plans, Validation Protocols, Validation Summary Reports, Standard Operating Procedures (SOPs), Manufacturing Specifications, Manufacturing and Packaging Batch Records.

• Performed Internal Audits for Bulk Chemical Plant Records.

• Generated the Annual Stability Lot Reports.

• Performed Investigation Reports for Medical/Non-Medical Customer Complaints from the QA standpoint.

• Created and executed Process Validation Protocols for Bulks Chemical Plant.

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