CARLOS MIMOSO

Senior Validation Engineer

**** ********** ****** ****

Apt. 2601

Jacksonville, FL

32256

xw2ghu@r.postjobfree.com

SUMMARY OF QUALIFICATION

• Committed, responsible, energetic and results oriented professional with experience (over ten years) in the pharmaceutical, medical devices environment and biotech industry.

• Excellent experience in the evaluation, organization and reporting of data obtained from validation and/or qualification studies to ensure that validation activities comply with company policies, government regulations and GMPs.

• Extensive knowledge on FDA Quality Regulations and Quality Management Systems. Proficient in QA procedures, CAPA’s “Corrective and Preventive Actions”, Gap Analysis, and many others quality related activities.

• Strong Knowledge of Equipment, Utilities, Facilities and Computer Systems Validations.

• Successfully worked in the development and/or execution of: URS/FRS/EDR/Risk Assessment/Traceability Matrix/ MVP/System and Device Assessments/FAT/SAT/Commissioning protocols/IQ/OQ/PQ/DQ/FQ/CSV; validation documents and final reports for facilities, utilities, HVAC, manufacturing equipment, packaging lines, product transfer line and other areas.

• Experienced in the development of equipments and process SOP’s, and trained the employees.

• Development and/or Execution protocols for the following systems: vision system, light color sensors, leak detectors, counter sensors, weight scale blenders (mixers), labelers, printers, cartoners, unscramblers, fillers, bundler and neck banders, coating systems, metal detectors, sweco, hardness testers, PTS, AHU, Solution tanks, Portable tanks, Solution pumps, Solution Preparation Systems, Compressed Air systems, weight scales, USP, VHP, Chillers, Boilers, HVAC systems, BMS, Delta V, and more.

• Experienced in Software Validation for systems such as: SCADA, SAP ERP 6.0, Solution Manager, and HP Quality Center, among others

• Develop turnover packages which included auditing vendor cut sheets, calibration record, engineering specification and drawings, redlining P&IDs etc.

• Experienced in a supervising role, in all validation activities such as: Commissioning and Qualification documents preparation and executions including the coordination of those activities.

• Strong knowledge of Microsoft Office, cGMP, GDP, OSHA, ISO9000, 21 CFR Part 11, 210, 211, 820, SDLC, GAMP 5, among others.

PROFESSIONAL EXPERIENCE

Philips / Healthcare, Andover, MA (From July 2011 to present)

• Software Quality Engineer/Assurance (SAP MCP Remediation Project for Philips Healthcare operations at Andover, MA; Seattle, WA) SAP ERP 6.0 system validation. Involved in the development, review and/or approval of the following SDLC deliverables: Part 11 Assessment, Remediation Plan, User Requirement Specifications, Functional Requirements Specifications, Traceability Matrix, Validation Test Plan, Validation Test Cases, Validation Test Scripts, Test Plans Summary Reports, Security Tests, Audit trail and Configuration Documents. Responsible to coordinate Validation activities with IT and Business.

Vistakon /J&J Vision Care, Jacksonville, FL (from February 2009 to June 2011)

• Senior Validation Engineer (Fusion Project; Phase 1 and 2) SAP ERP 6.0 system validation. Involved in the development, review and/or approval of the following SDLC deliverables: Part 11 Assessment, Compliance Analysis, Compliance Plan, Business Process Maps, User Requirement Specifications, Functional Requirements Specifications, Technical Design Specifications, Code Review, Risk Assessment, Traceability Matrix, Testing Strategy, System Test Cases, System Test Scripts, System Test Protocol, Compliance Report, and SOP’s. Coordinate and facilitate the Compliance/Validation meeting across the project teams: Development Team, Functional Process Owners, Business Owners, and Software Quality Engineers, in order to advance the project deliverables. Performed SQE approvals for test plans and test executions.

• Working in the Compliance and Validation activities for HP Quality Center, VDAS repository system, among others tools related to the SAP ERP 6.0 validation activities.

Amgen – Freemont, CA (from September 2008 to November 2008) in a Contract Position

• S&C Coordinator (BMX- AFB) Project. Responsible of the coordination of the system start up and also the TOP preparation for the following systems. Heating Hot Water, Chillers, Delta V, Cooling Tower and preparation tanks. The startups activities include but not limited the following tasks: installation verification with the vendors, loop checks, electrical verification, among others. The development of the TOP’s includes the following : Systems Walk downs and Drawings Red-lines, Welding, Isometrics Drawings, Piping, Pressure tests, Instrument Calibrations, I/O verifications among others verifications.

Novartis – Humacao, PR (from March 2008 to July 2008) in a Consultant Position

• Validation Consultant in the Qualification of the HVAC and Facilities modifications for Coating, Sorting, and Branding Areas. The Responsibilities included but not limited to generate the Qualification Assessments, Prepared the qualification protocols and perform the qualification execution.

Glaxo Smith Kline – Cidra, PR (from June 2006 to January 2008) in a Consultant Position

• Validation Project Leader in the Qualification of the transference of an existing Solution Preparation Area to a New Solution Preparation Area, and the Commissioning of various utilities systems such as: Boilers, Chillers and HVAC, including supervising the validation staff, validation activities coordination’s, preparation of: Validation Strategies with, URS, FRS, Validation Plans, Traceability Matrix, EDR, System Assessments, Commissioning Protocols, Qualification Protocols and Final Reports.

• Qualification of New Production Area (CCP project), including the Coating and Solution Preparation Qualification activities. Responsible of supervising a group in the preparation and execution of commissioning and qualification protocols for the coating accela-cota machines. All validation activities for the coaters systems included the mechanical qualification and the CSV. Also responsible of the preparation and execution of several protocols related to the Packaging Line Integration, Solution Preparation system among others qualification.

Bristol Myers Squibb – Humacao, PR (from February 2006 to June 2006) in a Consultant Position

• Qualifications of HVAC and manufacturing equipments, responsible of preparing and executing, IQ/OQ or Environmental Qualification Protocols, and final reports for: Powder Transfer System, Sweco System, SADE Sorters, Capsules Polisher, Facilities and HVAC Control Systems and BMS. Also responsible of preparing the equipments SOP’s and train employees.

Cordis LLC – San German, PR (from July 2005 to February 2006) in a Consultant Position

• Qualification of New Production Area, including the Facilities and Utilities Qualification activities. Responsible of preparing and executing commissioning and qualification protocols: Commissioning to new modifications of Crimp and Pack area, IQ/OQ to new modifications of Crimp and Pack area, Two IQ/OQ to the new manufacturing facilities. Worked on the execution of the Quadraflow Fume Hoods for new manufacturing modules. Give support to the internal quality team in the documentation reviewing process.

Ivax-Pralex – St. Croix, U.S. Virgin Island (from November 2004 to December 2004) in a Consultant Position- *Worked simultaneously with Pfizer-Vega Baja*

• Qualification of 4 New Safe line Metal Detectors (Equipments Validation Project). In charge of the IQ/OQ/PQ generation and execution for all detectors.

Pfizer – Vega Baja, PR (from March 2004 to March 2005) in a Consultant Position

• Qualification of New Production Area, (Azithromycin SR Project) Responsible of preparing and executing process, product, software, equipment, utilities and facility protocols (FAT, SAT, Commissioning, IQ/OQ, PQ and Final Reports) for Manufacturing and Packaging systems such as: Drum Lifters, Russell Compact Sieve, Metal Detectors, Capper Machine, Check Weightier, Milling Equipments, utilities and Packaging Line Integration (Filler, Metal Detector, Case Packer, Capper, Unscramble and Wrapper). Participated in the protocol execution of compliance with cGMP’s. Responsible of preparing and training employees in the SOP’s and PM’S, and coordinate the instruments calibrations for all instruments involved in the qualification of the (Azithromycin SR Project).

• Re-qualification of Existing Area, (Efferdent Recovery Project at Building 2) responsible of preparing and executing Facilities Commissioning and 3 Blenders IOQ including final reports. Involved in another activities such as: PCQP, TOP matrix, and instrument calibration coordination.

Mylan Inc. – Caguas, PR (from August 2003 to March 2004) in a fulltime Position

• Quality Assurance Leader. Responsible of the quality assurance of raw materials and manufacturing products, executed inspections such as: Product Uniformity, Friability, Hardness, Thickness, Weight Checks, Disintegration and Visual Inspections. Revised and approved Batch Records, Process Deviations, and Manufacturing Activities such as: Production Releases, Machine Set-Up and Cleaning Activities. Participates in the execution of various Process Validations and product transfers.

Pfizer – Caguas, PR (from September 1999 to August 2003) in a fulltime position

• Manufacturing Operator, Utility Operator and Batch Record Reviewer and compliance specialist. Expertise in the weighting process of raw materials, operation of filling machines (MG 100, MG 120, MG 140 and H&K), compression machines, coating and blending equipments, Packaging Lines. Also responsible of executing the equipments PM’s, incidents investigations, and revisions of production batch records among others.

PROFESSIONAL TRAINING

• Train the Trainer

• C&Q Guidelines

• Computer System Validation trainings

• Multiples trainings in cGMP’s, GDP’s, SOP’s, FDA, DEA, SDLC, FDA Quality Regulations, Quality System Trainings and OSHA regulations among others

• Pharmaceutical Facility and Utilities: Design, Validation & Operation

• HVAC/Facility Design and Environmental Monitoring for Pharmaceutical Plant

• Commissioning and Qualification Guidelines

• Safety in the Workplace

EDUCATION

1999-B.S. in Biology Major- Chemistry Minor

Universidad del Turabo – Gurabo, PR

Candidate Master Degree – Major Psychology

REFERENCES

Upon request

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