Lymari Serges Rodriguez
Patillas
Summary
Experienced Validation Specialist with background in assessing, improving and maintaining quality systems. Display strengths in technical knowledge, project management, and compliance with FDA regulations. Previous work resulted in improved validation processes, ensuring overall product safety and effectiveness. Demonstrated ability to communicate effectively with all levels of organization is key asset. Resourceful Quality Assurance Engineer well-versed in producing strong test cases and scripts for manual and automated testing. Skillful in training quality assurance staff, evaluating performance and improving procedures. Team-oriented and results-focused polished in helping developers spot and resolve issues. Experienced professional with a strong background in technology-related roles. Proficient in software development, system administration, and technical support. Skilled in problem-solving and optimizing performance. Capable of managing projects and collaborating effectively with teams. Committed to continuous learning and staying current with industry trends to contribute to organizational success.
Overview
17
17
years of professional experience
Work History
Validation Specialist
GSK and Haleon
Guayama
04.2021 - Current
- Generation and evaluations of the validation processes
- Create timelines as part of project related evaluations and activities
- Execution and Report of the Installation Qualification Protocol (IQ) and Operational Qualification Protocol (OQ) as part of the Qualification for Automation System and equipment in Qualified Building Management System (QBMS), Utilities Management System (UMS) and Process to Data Historian and Reporting System (PDHRS)
- Experience, management, generation and closure of the Change Control in SAP and Veeva System
- Experience, management, and identification of the Events or Deviation (Description of the Event, Root Cause, Impact Assessment, Corrective Actions, Preventive Actions, Further Actions Needed, Re-Testing, and Deviation Closure)
- Experience, management and generation the Periodic Review Report as part Qualification Status of Relevant Utilities
- Experiences and management the documents revision to a validation project for approval
- Generation the documents with the System Impact Assessment (SIA), User Requirement Specification (URS), Traceability Matrix (TM), Qualification Test Protocol and Qualification Summary Report (QSR)
Validation Specialist and Leader of Validation
Medtronic
Junco
05.2018 - 04.2021
- Generation and evaluations of the validation processes
- Create timelines as part of project related evaluations and activities
- Working with generation of manufacturing investigations, CAPA records and nonconformance (NC)
- Experience, management and identification the Discrepancy (Investigation, Corrective and Preventive Actions and Conclusion)
- Experience and management of the Addendum (ADD) / Amendment (AMD)
- Experience, management and generation Validation/ Qualification Assessment
- Management and Generation the Validation Plan Protocol (VP), Installation Qualification Protocol (IQ) / Factory Acceptance Test / Site Acceptance Test Protocol, Equipment Performance Results (EPR), Installation Qualification Report Protocol (IQR), Validation Plan Report (VPR), Operational Qualification Protocol (OQ), Operational Qualification Report (OQR) and Computer System Validation (CSV)
- Coordination of all activities and assessments and related with TMV, PC or PD, TFV, CSV and OQPQ
- Generation of the new instructions in a POD related with measurement as part test methods
- Giving of the training of the instructions related to new process, measurement, equipment, tool/ fixture and validation
- Generation of graphs as part of data collection and analysis in Minitab for the development of the TMV, PC, and OQPQ project
- Review the FMEA (Failure Mode and Effect Analysis) as part of the new change to implement
- Create the PCH, RCH and new Documents for approval in MAP Agile system as part the new change to implement
- Coordinate all activities as part of a project in the manufacturing area to implement the new change and execution with WO (Work Order)
- Create, assessments and review a Process Operating Document (POD) and Work Instructions (WI)
- Review and approval of the validation protocols, documents and PODs related to the manufacturing process using Agile MAP System
- Experience in working to molding process (Mold and PINs) with rubber in manufacture area and final pack process
- Knowledge in the systems of the Quality Management System (QMS), Enovia, SAP, MAP Agile, EQDMS and Trackwise
Cleaning Validation Specialist
Bristol-Myers Squibb
Humacao
03.2017 - 08.2017
- Working with a project the assessments in cleaning and sample point in all the equipment in manufacture area for generation the new ASM and Procedure (PROC) as part the procedure revision in cleaning
- Giving the training format to all that apply
- Working different binders of cleaning validation and reports of cleaning qualification for different equipment
- Verify coordination the cleaning and the taking of sampling point the equipment by the training personnel in the execution protocol
- Generate the cleaning reports for equipment in the manufacturing area
- Binder mounting the Final Report Cleaning Validation for SS Bins, Plastic Bins, Isolator, API Container’s and Roller Compactor
- Binder mounting the Final Report Cleaning Equipment Holding Time (CEHT) for Plastic Bin is selected as the worst case
- Data gathering for mounting the binders
- Search sampling results of microbiology for the binder
- Search the cleaning form and logbook (chronological book) the equipment for analysis and generation the table in Excel for summary of the campaign length, DEHT and CEHT
- Organization the meeting with engineers, supervisor and manager about that need for complete the binder
- Verification, organization and correction the documents in the binder of SS and Plastic Bins, Granulation and following the good practice the documentation
- Following up all tasks and status with relation binder the cleaning report
- This cleaning validation exercise included the evaluation of the cleaning parameters campaign length and dirty equipment holding time (DEHT)
- Search the qualification reports the equipment and critical utilities (city water, purified water and compressed air) used during this cleaning validation exercise were previously qualified is included in the binder of cleaning reports
- Analysis and identification the discrepancy and investigation in the binder of cleaning reports
- Worked with collection and analysis data for the development of the cleaning validation activities, for analytical development with result obtained using the Excel Program
- Assured the personnel that participate in the cleaning validation execution were trained on protocol and the cleaning procedures used for cleaning process
- Working with a project on the area surface for equipment measures
- For determination of the area surface in contact with product is sufficient for the area to be sampled
- Working with generation of manufacturing investigations, CAPA records and nonconformance (NC)
- Experience, management and identification the Discrepancy (Investigation, Corrective and Preventive Actions and Conclusion)
Quality Assurance
Amgen
Junco
01.2018 - 04.2017
- Working in a project the decommissioning for formulation and filling equipment of syringe and vials, facilities and systems
- Review and approved the documents of the SOP, decommissioning Protocols (generated and execution) of the equipment in area the formulation and filling for the decommissioning
- Verification of all documents related to the decommissioned project that includes NC’s, Work Order, CAPA, Change Controls (CCs), EHS documents, Maximo (Calibration, asset status, WO status), Computerized System (Backup and PI data), review and approved of discrepancy and verification in the area the equipment with under decommissioned (Out of service)
- Working with the systems of Maximo and EDMQ for approved of documents
- Verification the CC (Parents and child) about the status
Cleaning Validation Specialist
Bristol-Myers Squibb
Humacao
10.2016 - 02.2017
- Working different binders of cleaning validation and qualification
- Binder mounting the Final Report Cleaning Validation Protocol for compression stage the Fette 3090i-Wip Tablet Press
- Binder mounting the Final Report Cleaning Equipment Holding Time (CEHT) for Plastic Bin is selected as the worst case
- Binder mounting the Final Report Cleaning Validation Protocol for Plastic and Stainless-Steel Bins
- Data gathering for mounting the binders
- Search for sampling results of microbiology and Active for the binder
- Search evidence training of the cleaning forms for Fette 3090i-Wip Tablet Press and Plastic and Stainless-Steel Bins
- Search the different version the cleaning form for the Fettes and Plastic and SS bines for analysis and generation the table in Excel
- Summary of Cleaning Monitoring Performed in Compression Stage, CEHT, Plastic, and Stainless-Steel Bins
- Organization the meeting with engineers, supervisor and manager about that need for complete the binder
- Verification, organization and correction the documents in the binder of Compression, CEHT, Granulation, Weighing and Plastic and Stainless-Steel Bins following the good practice the documentation
- Following up all tasks and status with relation binder mounting
- Working with generation of manufacturing investigations, CAPA records and nonconformance (NC)
- Experience, management and identification the Discrepancy (Investigation, Corrective and Preventive Actions and Conclusion)
- This cleaning validation exercise included the evaluation of the cleaning parameters campaign length and dirty equipment holding time (DEHT)
- Searching for the qualification reports the equipment and critical utilities (city water, purified water and compressed air) used during this cleaning validation exercise were previously qualified is included in the binder of compression, CEHT, Plastic and Stainless-Steel Bins
- Analysis and identification the discrepancy and investigation in the binder mounting
- Worked with collection and analysis data for the development of the cleaning validation activities, for analytical development with result obtained using the Excel Program
- Search the supporting documentation for the binder of compression, granulation, weighing and plastic & Stainless-Steel Bins
- Assured the portable equipment was calibrated when using in the run protocol
- Assured the personnel that participate in the cleaning validation execution were trained on protocol and the cleaning procedures used for cleaning process
Validation Specialist
Zimmer Biomed
Ponce
05.2016 - 09.2016
- Generate the Validation Plan (VP), Installation Qualification Protocol (IQ) and Equipment Performance Results (EPR) in equipment required complete CSV and TMV
- Giving training of procedures for new instruction the gages (Project TMV)
- Create and give training for Operator Total Productive (TPM) sheets in an equipment Measuring System with Software
- Generate new instruction for the different gages (Digital Caliper, Position Gage, Distal Tip Gage, Thread Gage, Plug Gage, Hole Gage and Standard Gage, micrometer gage, digimatic indicator, Radius Gage, Surface Roughness, groove width, federal bench gage & master diameter ring, position gage)
- Generate Master Table in Excel for the Project TMV with FIP or FCA, MIS (Measurement Inspection Sheet) and Part number
- Assured the portable equipment was calibrated when using in the run protocol
- Worked with collection and analysis data for the development of the project TMV, with analysis to Blueprints Inspection
- Checking the FIP (Feature Inspection Plan) or FCA (Feature Criticality Assessment) for the Project TMV
- Generation the Test Method Validation Protocol (TMV) and verify Test Method Validation Report (TMVR)
- Generation the Change Request/ approval for execution form (change Control Number)
- Generation the form to the Project/ Parent Validation Number
- Generation the form (Financial) to Relocation for equipment
- Coordination all activities to the project for equipment Measuring System with Software
- Generation of new methods for gages in medical devices
- An evaluation and validation of the methods that existed in manufacture area
Validation Specialist and Leader of Validation
Zimmer Biomet
Ponce
10.2014 - 10.2015
- Experience in Specialist Cleaning Validation the Medical devices
- Worked with collection and analysis data for the development of the cleaning validation activities, for analytical development with result obtained using the Excel Program
- Experience as Leader in Cleaning Validation of New Equipment and Process
- Experiences to evaluate validation activities and documentation as Quality Specialist to ensure that they meet FDA standards, corporate/governmental policies and regulations and those of other regulatory agencies
- Process development for Cleaning, management and generation the Validation Plan Protocol (VP), Installation Qualification Protocol (IQ) / Factory Acceptance Test / Site Acceptance Test Protocol, Equipment Performance Results (EPR), Installation Qualification Report Protocol (IQR), Validation Plan Report (VPR), Operational Qualification Protocol (OQ), Operational Qualification Report (OQR) and Computer System Validation (CSV)
- Generation strategies work in validation for cleaning equipment of medical devices for Process Validation
- Equipment qualifications cleaning in the manufacturing area (Equipment: Branson, Glove Box, Gramillys and Miele)
- Experiences and management the process the Utilities and facilities with Air, (Filters) Water (DI Water, Soft Water, City Water or Better), all parameters for the room (Temperature and Humidity) and drawings
- Working with generation of manufacturing investigations, CAPA records and nonconformance (NC)
- Experience, management and identification the Discrepancy (Investigation, Corrective and Preventive Actions and Conclusion)
- Experiences and management the documents revision to a validation project for approval
- Identification of the GAP on the procedures, validations, SOP forms
- Experience, management and generation the validation for equipment of cleaning new and validation equipment existent (re-validation)
- Assured the portable equipment was calibrated when using in the run protocol
- Responsible for all repair activities of existing equipment for re-validation
- Generation the validation of Commissioning Protocol and Commissioning Report Protocol / Decommissioning Protocol and Decommissioning Report Protocol
- Experience, management and identification the Discrepancy (Investigation, Corrective and Preventive Actions and Conclusion)
- Experience and management of the Addendum (ADD) / Amendment (AMD)
- Experience, management and generation Validation/ Qualification Assessment
- Experience the transmittal validation qualification
- Generation and management of changes procedures for cleaning validation
- Experience providing training procedures on the changes generated the same for all operators and engineers
- Generation Change Control Number (CC) and Change Management System Number (MC)
- Closure the Change Control Number (CC) and Change Management System Number (MC)
- Responsible for designing a complete project single for validation
- Experience and management of the validation work in a group with team leader
- Experience running validation (IQ) and test for equipment (ITP)
- Participates in projects, programs, safety and environmental activities, cGMP and procedures’ training, special company activities and others, as required necessary
- Experience in cleaning equipment ultrasonic and cavitation monitoring for validation
- Experience and management of process monitoring parameters and control limits
- Experience of the equipment is used as a manufacturing aid, intermediate cleaning, and complete cleaning for medical devices
Laboratory Auditor and Validation Specialist
Water Treatment Plant
Patillas
01.2009 - 02.2010
- Performed testing activities and assured compliance with Standard Test Methods
- Developed, wrote and revised RPT and SOP’s
- Monitored the testing techniques
- Assured the laboratory equipment was qualified, calibrated and within program
Validation Specialist
Water Treatment Laboratory
Chicago
03.2008 - 08.2008
- Supervised the testing activities microbiology to assure compliance to Standard Test Methods
- Ensured that all documentation was prepared and reviewed, as required
- Executed sterilization, protocols, ECA excursions, micro investigation, TI and specifications
- Provided training, operated and troubleshot microbiology laboratory equipment
- Performed quality, environmental monitoring and sterilization processes
- Performed microbial identification and monitoring environmental process
- Assured all annual ECA re-certifications were executed by schedule
- Assured that final test report was approved
- Established environmental objectives and targets for the area that will provide continuous environmental improvements
- Monitored the testing techniques and verified accuracy of all records and documentation that was done in the microbiology laboratory
- Increased efficiency in microbiology laboratory, solved problems generated during validations, improved and provided support
- Assured laboratory equipment was qualified, calibrated and within program
Education
M.D. - General Medicine
University Central Del Este
Santo Domingo, RD06-2007
Bachelor of Science - Biology
Interamerican University
Ponce, PR06-2003
Skills
- Validation protocols
- Change management
- Regulatory compliance
- Data analysis
- Risk assessment
- Project management
- Quality assurance
- Equipment qualification
- Training development
- SOP creation
- Event investigation
- Root cause analysis
- Team collaboration
- Effective communication
- Documentation management
- GMP auditing
- Sterilization validation
- Software validation
- Process validation
- Facility validation
- Computer system validation
- Data integrity
- CAPA management
- Test method validation
- Change control
- Cleaning validation
- Record keeping
- Measurements and analysis
- Design control
- Quality management systems
- GMP compliance
- Validation master plans
- Process analysis
- Testing protocols
- ISO standards
- FDA regulations
- Regulatory guidelines
- Data interpretation
- Troubleshooting
- Analytical thinking
- Task prioritization
- Teamwork
- Documentation control
- Good manufacturing practices
- Technical reporting
- Self-motivation
- Recommend resolution strategies
- Root-cause analysis
- Manufacturing operations
- Validation documentation management
- Product verification
- Excellent communication
Languages
Spanish
First Language
English
Upper Intermediate (B2)
B2
Italian
Elementary (A2)
A2
Timeline
Validation Specialist
GSK and Haleon
04.2021 - Current
Validation Specialist and Leader of Validation
Medtronic
05.2018 - 04.2021
Quality Assurance
Amgen
01.2018 - 04.2017
Cleaning Validation Specialist
Bristol-Myers Squibb
03.2017 - 08.2017
Cleaning Validation Specialist
Bristol-Myers Squibb
10.2016 - 02.2017
Validation Specialist
Zimmer Biomed
05.2016 - 09.2016
Validation Specialist and Leader of Validation
Zimmer Biomet
10.2014 - 10.2015
Laboratory Auditor and Validation Specialist
Water Treatment Plant
01.2009 - 02.2010
Validation Specialist
Water Treatment Laboratory
03.2008 - 08.2008
M.D. - General Medicine
University Central Del Este
Bachelor of Science - Biology
Interamerican University
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