Emilio Almodóvar
Wyncote,USA
Summary
Manufacturing & Validation Engineer professional with extensive experience in the Pharmaceutical, Medical Device and Electronics industries in the areas of Quality, Regulatory, Manufacturing, Process, Technical Support, Commissioning and Qualification, Validation, and CSV, among others.
Overview
36
36
years of professional experience
1
1
Certification
Work History
Validation Consultant
Janssen Johnson and Johnson
Malvern, Pennsylvania
11.2023 - 01.2025
- Execute Perform IOQ & PQ for laboratory equipment.
- Execute IQ, OQ and PQ & Testing Plan Protocols and Report for Thermo Fisher Freezers and Incubator Chamber (35 to -70 C).
- Execute IQ, OQ and PQ & Testing Plan Protocols and Report for Walk In Freezers and Cryo Chamber (-5 to -196 C).
- Commissioning Laboratories Instruments.
- Execute IOQ Laboratories Instrument Validation (Nucleo Counter) in compliance with 21 CFR part 11.
- Standard Operational Procedures of new chamber equipment.
- Maintenance Procedures for new chamber equipment.
- Interconnect Thermo Fisher Chamber temperature controller to Yokogawa Panel Recorder.
- Providing engineering guidance for equipment.
- Support equipment and/or GMP manufacturing facilities and laboratory areas.
Validation Engineer
Merck
Las Piedras, Puerto Rico
03.2023 - 08.2023
- Execute IOQ for Mettler-Toledo Scale and balance for to fulfil with ALCOA+ and connecting to a new MES PAS-X V3.
- Execute IOQ Testing Plan Protocols and Report using Kneat eVal.
- Execute IOQ Instrument Validation(Mettler-Toledo Scale and balance) in compliance with 21 CFR part 11.
- Write Standard Operational Procedures for instrument and equipment.
- Maintenance Procedures ensuring GMP status of equipment.
- Execute Mapping Temperature Studies in Warehouse Layout for Temperature Balancing.
Validation Engineer
AstraZeneca
Canovanas, Puerto Rico
11.2022 - 02.2023
- Execute all Computer System Validation Life Cycle for COTS System and Integrity Test Filter, write and perform:
- Supplier Audit Report
- Design Specification (DS)
- User Requirement and Matrix Traceability (URS and MT)
- Functional Specification (FS)
- Functional Risk Assessment (FMEA)
- Change Control, Configuration and Document Management (CC and DM)
- Risk Classification (RC)
- Environmental Health Safety Assessment (EHS Assessment)
- Commission Equipment
- Create equipment in GVLMS data system
- Calibration Order in Cal Pro data system
- Create equipment in SAP
- Functional Acceptance Test
- Site Acceptance Test (Dry Run)
- IOQ Testing Plan and Report
- Execute IOQ Laboratories Instrument Validation (Integrity Test Filter) in compliance with 21 CFR part 11
- Standard Operational Procedures
Sr. Engineer, System Owner
Amgen
Juncos, Puerto Rico
09.2021 - 09.2022
- Execute assessment for implementation on packaging lines with Systech System as System Owner new product for international market.
- Execute Work Order instructions and upload using Maximo for equipment Domino Printer, Cognex Visual Inspection Camera, Near Line Automated Printing and Inspection System HMI, AFP Segmentation Systech Advisor, AFP Segmentation Systech Remote, AFP Segmentation Laser Printer, Serialization Intelli-Code Systech Advisor, Serialization Intelli-Pac Sentri 01, Intelli-Code Domino Laser Printer 320i implements on packaging lines 4125, 4126 and 322 for international products market.
- Execute Protocols (PTC) of printing labels and printing cartons for implemented new serialized products in the packaging lines for the international market.
- Execute Work Order instructions as viewer with the Automation Engineer on packaging lines 4125, 4126 and 322 for Random Serialized Packaging Printing and Non-Serialized Packaging Printing.
- Execute redlines and revisions of documents in Veeva Vault CDOCS.
- Work with TR’s, CFSCR and GDE in Track Wise.
- Work with item numbers for Stock Keeping Unit (SKU) thru SAP.
- Execute updates, reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment.
- Troubleshooting packaging equipment, labeling and cartoon printing, conveyors, scale and Cognex visual inspection.
Engineering Spec
Medtronic
Juncos, Puerto Rico
04.2006 - 09.2021
- Write standard operating procedures SOP for packaging and production process.
- Write maintenance procedure for equipment in manufacturing and packaging process.
- Execute of line trials, engineering studies, equipment qualification and process performance qualification.
- Troubleshooting and repair equipment with PLC Allen Bradley, Siemens, Omron and Keyence as part of automation system.
- Commissioning Process and Instruments Equipment.
- Troubleshooting and repair equipment with Emerson DeltaV and Allen Bradley DCS.
- Work and execute Project for Manufacturing Improve Yield using Six Sigma, Lean Sigma and DAMAIC tools to reduce cost.
- Supports, executes and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
- Develop a Master Maintenance Plan in the spare parts and job plan area using SAP.
- Develop business case and scope of work.
- Training and certified personnel for manufacturing process.
- Execute CSV project for update Factory Works (Manufacturing Execution System and automation process used by Medtronic).
- Execute IOQ Equipment Validation (Plasma Cleaner) in compliance with 21 CFR part 11.
- Execute CAPA and Non-Conformance Investigation and Deviation Management Investigation.
- Execute Instrumentation Out of Tolerance and Non-Conformance investigation.
- Implement Engineering Change Order (ECO) including new parts.
- As part of the remediation strategy under the Consent Decree with the FDA, full-time support was provided to CAPAs (Corrective Action/Preventive Actions) involved with the different equipment, process assessment and validation remediation activities.
- Troubleshooting and execute validation of equipment (example conveyors) with Cognex (Dataman software) and Keyence for read ID Matrix (QR) and Barcode.
- Complies with all the requirements in the operational procedures at the area of responsibility to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR’s).
- Support New Product Department implementing: quality plans, quality risk assessment, risk analysis, FMEAs documents and systems in a team with other product development members.
- Execute Engineering Technical Report.
- Execute Six Sigma Project.
- Use of measurement of DMM, Tachometer, Temperature Device as Vaisala and Kaye Validator, Pressure Gauge.
- Troubleshooting and repair equipment as Ph Lab measurement, Centrifuge and Plasma Clean.
- Project Management and execute capital project.
- Execute Safety and Environmental risk assessments for manufacturing and process line.
- I have established compliances safety programs after studies and assessment as Machine Guards, LOTO and Manufacturing Ergonomic.
- Decommissioning Equipment.
Project Technician
Ciba Vision
Cidra, Puerto Rico
01.1997 - 04.2004
- Project for developed and executed a new automated lathe machine for the manufacturing of contact lenses.
- Execute Validation of new automated lathe machine including: User Requirement Specifications, Functional Design Specification, Protocols (Installation Qualification, Operational Qualification, Performance Qualifications documents for qualifications (protocols or plan and reports including deviation).
- Troubleshooting of electromechanical equipment (West Capper, Cozzoli Filler, Opto Form and Zebra Printer labelling) with PLC (Omron and Keyence), Sensors, Pneumatics and Laser parts.
- Provides on-the-floor support for project implementation and studies, as required.
Manufacturing Technician
Intel
Las Piedras, Puerto Rico
04.1994 - 01.1997
- Troubleshooting and Repair of Intel Motherboard with Pentium Processor in the Automatic Test Equipment (ATE) station (In-circuit test HP3070).
- Troubleshooting and Repair of Intel Motherboard with Pentium Processor in the Functional Assurance Test (FAT) station.
- Support Develop and Design Team on analysis of P.C.I. Computer Architecture.
Gel Dipping Operator
Mc Neil Consumer
Las Piedras, Puerto Rico
09.1993 - 04.1994
- Operate Geldipping manufacturing machines.
- Support to Validation Team in executes Qualification.
Instrument Technician Coop Student
Alcon
Humacao, Puerto Rico
09.1988 - 07.1993
- Execute Calibration of pressure test gauge using Ametek Dead-Weight Tester.
- Execute Calibration of temperature and humidity recorders.
- Execute Calibration of pH meters.
- Execute Calibration of equipment with 4-20mV transmitter.
- Execute Thermometer and calliper verification.
- Execute Perform Millipore Integrity Test Filter.
Education
Bachelor of Science - Electrical Engineering
University of Turabo
Gurabo, Puerto RicoBachelor of Science - Physics Applied to the Electronic
University of Puerto Rico
Humacao, Puerto RicoSkills
- Quality Assurance
- United States and European GMPs
- CFRs
- FAT
- SAT
- URS
- Commissioning and Qualification
- Validations
- Analytical Thinking
- Quality and Results Oriented
- Technical Writing
- Deviation Management Investigation
- Leadership and coaching skills
- Self-Starter
- Security Clearance: Secret
- Teamwork
- Continues Improvement
- Communications
- Training in Serialized Packaging Printing
Certification
- OSHA Certification, 10 Hr 29 CFR part 1910 General Industry Safety and Health
- Hazmat Cargo Certified Certification, 49 CFR SHIPPING AND TRANSPORTING OF HAZARDOUS MATERIALS part 100-185
Computer Controls
- MS Office (Word, Excel, PowerPoint, Access, Works, Outlook, Publisher, etc.)
- Trackwise
- EQDMS
- SAP
- MAP Agile
- Factory Works
- National Instrument Multisim
- MathLab
- S.P.I.C.E
- DOS Operating System
- Unix System
- C++ Programming Language
- Fortran Programming Language
- Scada Citect with HMI ver 6.0 r
- Minitab
- Maximo
- Veeva Vault CDOCS
- Kneat eVal
- ELN Biovia
Quality Systems
- SOPs
- Document Control
- CAPA
- Non-conformance investigation
- Out of Tolerance Investigation and Report
- Management of Quality Hold
- Root Cause Analysis (DMAIC and A3)
- Data integrity (ALCOA)
Industries
- Medical Devices
- Pharmaceutical
- Laboratories
- Biotechnology
- Electronic / Computer
Timeline
Validation Consultant
Janssen Johnson and Johnson
11.2023 - 01.2025
Validation Engineer
Merck
03.2023 - 08.2023
Validation Engineer
AstraZeneca
11.2022 - 02.2023
Sr. Engineer, System Owner
Amgen
09.2021 - 09.2022
Engineering Spec
Medtronic
04.2006 - 09.2021
Project Technician
Ciba Vision
01.1997 - 04.2004
Manufacturing Technician
Intel
04.1994 - 01.1997
Gel Dipping Operator
Mc Neil Consumer
09.1993 - 04.1994
Instrument Technician Coop Student
Alcon
09.1988 - 07.1993
Bachelor of Science - Electrical Engineering
University of Turabo
Bachelor of Science - Physics Applied to the Electronic
University of Puerto Rico
Similar Profiles
GINA DURANGINA DURAN
Field Reimbursement Manager at Johnson & Johnson, Janssen PharmaceuticalsField Reimbursement Manager at Johnson & Johnson, Janssen Pharmaceuticals
Shanica JeffriesShanica Jeffries
Reimbursement Specialist at Johnson & Johnson, Janssen PharmaceuticalsReimbursement Specialist at Johnson & Johnson, Janssen Pharmaceuticals
Traci SpaldingTraci Spalding
Sr. Director, National Accounts, Strategic Customer Group at Janssen Pharmaceutical Companies of Johnson & JohnsonSr. Director, National Accounts, Strategic Customer Group at Janssen Pharmaceutical Companies of Johnson & Johnson
NORDIA LYNCHNORDIA LYNCH
Licensed Practical Nurse at ClipboardLicensed Practical Nurse at Clipboard
Crisona EdmundsCrisona Edmunds
Event Staff at Lincoln Financial FieldEvent Staff at Lincoln Financial Field