Customer Service Engineering

Karis M. Vargas González

PO Box ****

Hormigueros, PR 00660

Mobile: 787-***-**** E-mail: ************@*****.***

OBJECTIVE

Seeking a challenging position in the pharmaceutical, medical device and biotechnology industries where I can utilize my abilities and experience to make positive contributions in the attainments of company goals and professional enhancement.

SUMMARY OF QUALIFICATIONS

Team oriented professional with over fourteen (14) years as a validation consultant in Medical Device and Pharmaceutical Quality. Experience with system validation and manufacturing implementation to maximize efficiency while maintaining high product quality that meets customer and international standards.

Proficiency with Medical Device Product Certifications, Test Method Validation, Cleaning Validations, Equipment qualifications, Process Transfer, and Manufacturing Process development/ improvement.

Validation activities including but not limited to coordination and execution of field activities, development of validation and engineering protocols, final reports, investigations, technical reports among others.

Analyzed validation data, generated conclusions, and recommended statistical based evaluations to implement enhancements for validated processes that met validation guidelines to guarantee compliance with current practices/policies.

Validation experience with: Process Transfer, Product Transfer, CIP, Vial Washer Machine, Vacuum Drying Oven, Biological Safety Cabinets, Nitrogen Staging Boxes, Refrigerators, Ultra-microbalances, Stereomicroscopes, Ionizing Air Blowers, Ionizing Air Guns, Vacuum Pumps, Label Printers, Spray Coating Carts, Bench Scale, pH/Conductivity Meter, Freeze Dryer Machine, Moisture Determination Equipment (Computrac), Optical Comparators (Nikon/Mitutoyo), Pull Tester, Pressure Gauge, Gas Chromatograph, TOC Analyzer and Software Qualifications.

PROFESSIONAL EXPERIENCES

Independent Consultant (Añasco, PR) 2015-Present

Sr. Validation Specialist / Project Engineer

Facilities, Equipment and Process Qualification: Responsible for the generation of the qualification documentation such as Change Control documentation and Qualification protocols/reports (IOQ/PQ) for a new manufacturing clean room, equipment for the new manufacturing area and validation of the new manufacturing process.

Equipment and Test Method Validation: Responsible for the qualification activities of a Gas Chromatograph and a Total Organic Carbon Analyzer. Generated Change Request documents, Qualification protocols/reports (IOQ/PQ) and Test Method Validation documentation. Developed standard operating procedures for the equipment and trained personnel.

Process and Product Transfer validation: Responsible for the validation and qualification of a new drug loading, freeze drying and packaging process of a new product for domestic (US) market. Generated Qualification Protocols (PQ/PV) and applicable reports. Responsible for the generation of new standard operating procedures to fulfill process requirements. Responsible for the training deployment to the manufacturing operators. Responsible for the manufacturing area readiness, coordination of testing, material handling and release of validation lots.

Computer System Validation: Responsible for the generation of CSV life cycle documents such as Validation Plan, Change Control, URS, FRS, SDS, Test Plan, Operational Qualification, Performance Qualification, Part 11/Annex 11 and Traceability Matrix in order to challenge that the system complied with 21CFR Part 11 Regulation for Electronic Records.

Equipment and Process Validation Team member: Responsible for the DOE studies to define correct parameters for a new sealing tool. Responsible for the Installation, Operational and Performance qualification of the sealing tool. Work in conjunction with the drafting department in the generation of the sealing tool drawings. Responsible for the Process Validation of the sterile and non-sterile products in which the sealing tool is used.

BMS / AccuReg, Inc. (Florida, US) 2014-2015

Quality Engineer and Sr. Validation Consultant

Test Method Characterization and Test Method Validation. Responsible for generating applicable protocols and reports for Incoming Inspection and Manufacturing areas visual and dimensional inspection as well as final release criteria functional testing. Supported all related execution activities such as conforming and non-conforming sample generation, protocol training, personnel availability.

Developed manufacturing work instructions for the visual and dimensional verification of subassemblies received from molding process at the Incoming Inspection area. Responsible for document deployment and training to impacted area personnel.

Generated Installation Qualification protocols and reports for visual inspection equipment.

Integra NeuroSciences (Añasco, PR) 2011-2014

Sr. Validation Specialist

New Process and Product Transfer Team Member. Responsible of generating Equipment Commissioning documentation and Process/Equipment Qualification Protocols (IQ/OQ/PQ) and applicable reports. Performed Test Method development in conjunction with outside vendors. Directly support DOE and Engineering Runs for process cycle optimization; also coordinated strategic activities such as sample testing and personnel needs.

Completed Computer System Validation (CSV) life cycle deliverables for required equipment. Deliverables include: Risk Assessment and GAP Analysis, Validation Plan, User Requirement Specification, System Design Specification, Test Plan, Traceability Matrix, Security and Administration Procedures.

Develop prototype manufacturing standard operating procedures for the BioPatch Drug Loading and Freeze Drying Process units. Prepared applicable Engineering Notice to issue the procedures for the new process steps.

Responsible for the process and equipment cleaning evaluations. Develop Cleaning Engineering Runs to determine effectiveness of the proposed cleaning methods and procedures.

Coordinated equipment calibrations with external suppliers in conjunction with the Calibration department. Involved in the evaluation, purchase requisition and purchase order placement in PRMS system for the required equipment, instrumentation and consumables for the new manufacturing process. Suppliers follow up until equipment delivery and final payments issuance.

Part of the Risk Analysis, Failure Mode and Effect Analysis (FMEA), Medical Devise Hazard Analysis (MDHA) and Validation Master Plan documentation development team.

Label Approval Initiative Team Member: Responsible for the review of the CUSA Family Product Change Notice (CN) packages received from our external clients. Provided feedbacks on findings related to the proposed label changes. Prepared Label Approval Form packages to implement the changes. Requested new part numbers for the new labels. Performed dry runs for the final label art and layout in conjunction with the Drafting department. Also collaborated in the audit performed to all the label approval packages for the BSI Labeling project.

Weil Group, Inc. (Caguas, PR) 2002-2011

Validation Specialist / Sr. Validation Specialist

New Product Development, Process and Product Transfer Team Member. Performed process analysis. Completion of the deliverables for project reviews (such as, but not limited to project charter, project plan, risk assessment). Addressed Change Management Strategies and deliverables. Developed Strategic Qualification Protocols/Reports (PQ/PPQ), Engineering Studies (for parameter determination), Product and Drug Stability Protocols, and Confirmation Runs. Coordinated and supported strategic qualification activity (such as planning, lot scheduling, materials; solution preparation; documentation; manufacturing area readiness; training to involved personnel from manufacturing, QA, technicians, laboratory, supervisors, shipping to engineering associates).

Prepared Equipment/Process Qualification Protocols/Reports (IQ/OQ/PQ). Prepared and executed Engineering Studies and Review Qualification Protocols for Equipment and Software. Trained operators, technicians and engineers.

Supported PPQ activities for US market and EU market products. Coordinated multifunctional disciplines such as QA, Analytical Laboratories, and Microbiology Laboratories during validation execution. Addressed manufacturing incidents, protocols and procedure deviations. Coordinated with Engineer and Technicians maintenance and calibration of spray coating machines. Conducted follow up and status meetings regarding protocol progress. Coordinated on samples off site delivery.

Modified and created Batch Records Documents, Manufacturing Work Instructions (SOP) and Departmental Procedures. Responsible for the Personnel Training.

Prepared Change Request, Change Control Records, System Application Forms, Validation Strategies and Change Based Validation Strategies.

Developed, investigated, resolved and managed Non-Product Non-Conformances and Deviation Reports related to process, product and equipment qualifications.

Prepared Maximo New Equipment Inventory and PM Request Form, Equipment Classification Specification Sheet and Maximo Equipment Spare Parts Form.

QA Auditor

Performed Quality Assurance Laboratory batch records audits. Reinforced procedure compliance. Trained laboratory personnel in cGMP documentation standard operating procedures (SOP).

Preformed trending analysis to monitor performance and improvement in audit findings.

Member of a group of 4 professionals providing Product Quality Data to the Worldwide Cordis LLC, organization. Developed, qualified and administrated a web- based database containing lot manufacturing, laboratory analytical results, sterilization, and shipment data.

Validation Technician

Prepared and executed Qualification Protocols/Reports (IQ/OQ/PQ), Engineering Studies and Review Qualification Protocols for Cleaning Validation. Prepares and gave protocol training to operators and technicians.

Generated, reviewed and close deviations, amendments and addendum documents.

Directed contact with external laboratories for sampling and testing coordination during and after cleaning qualification.

Projects:

OMJ Pharmaceuticals (San Germán, Puerto Rico) – Cleaning Validation, Standard Operating Procedures.

Cordis, LLC (San Germán, Puerto Rico) – Quality Assurance Laboratory Auditor; World Wide Quality Assurance Data Base; Technical Operations Support (all related activities of Equipment Qualification, Performance Qualification and Product Performance Qualification); UBD Parylene and WIP Drying Vacuum Ovens; UBD Module 4 and Module 5 Spray Coating Carts Projects; Strategic Operations Support (Manufacturing and UBD Spray Coating Carts Qualification); Development and Modification of Standard Operating Procedures and Manufacturing Work Instructions; Sustaining Engineering Projects Support (New and Existing Product Development).

Abbott Laboratories - (Barceloneta, PR) 2001-2002

Laboratory Analyst

Analyzed water samples from the treatment plant in order to monitor used water quality.

Developed calibration and operating procedures for laboratory equipment. Performed calibration and trouble shooting of laboratory instrumentation.

In charge of the review and update to current procedures.

MetroTech Corp. - (San Lorenzo, PR) 2000-2001

Sales and Technical Support Representative

Customer service provider. Generated laboratory instrumentation quotations. Follow up on purchase requisition until placement of purchase order. Ensure equipment delivery in a timely manner. Performed presentation and market introduction of new laboratory equipment.

General knowledge in equipment calibration, such as: titrators, balances, pH meters, conductimeters, and ovens. Coordinated calibration of laboratory equipment and qualification packages.

Part of an ISO 17025 implementation committee for the Metrology Laboratory accreditation.

EDUCATION

Bachelor of Science, Major in Chemistry. University of Puerto Rico, Mayagüez PR.

Member of the American Chemical Society (ACS)

SKILLS

Knowledge of cGMP and FDA regulations.

Teamwork oriented.

Computer literate (Microsoft Word, Microsoft Excel, Power Point, Visio, Microsoft Project, Visio, MiniTab, PRMS, CPDM, Agile).

Excellent oral and written communications skills in English and Spanish.

CERTIFICATIONS:

Six Sigma Black Belt training completed.

Medical Devices Compliance training completed. Certification received.

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