Milton A. Martinez Mercado
10 Highpoint Cir Apt 204, Quincy,MA
Summary
Focused and determined Validation Engineer with over 4 years of experience in the Pharmaceutical Industry. Has strong organizational skills and a strong eye for detail. Able to learn fast and adapt to changing circumstances.
Overview
7
7
years of professional experience
Work History
Moderna Therapeutics, Lead Validation Engineer
Escalate Life Sciences
01.2023 - Current
- Worked on requalification for SKAN equipment.
- Executed ssDNA Installation and Operational Qualifications (IOQs) and provided support in cleanroom qualifications.
- Executed FTUs Addendum qualifications for 10 and 5 litters bag recipes.
- Provided support on FDA observation remediation protocol.
- Scheduled coordination of requalification for CTUs and periodic reviews for more than 600 FUSE equipment in all sites of Moderna facility.
- Actively involved in the coordination and logistic of Ellab equipment for validation teams in all sites of Moderna facility in order to meet requalification deadlines.
- Provided guidance, subject matter expertise, and support to validation engineers.
- Ensured that the validated state of the equipment is established in accordance with internal procedures, regulatory equipment, and industry standard.
- Executed CTUs temperature mappings and periodic reviews across sites.
- Met tight deadlines to satisfy client demands and project timelines.
Moderna Therapeutics, Validation Engineer
Escalate Life Sciences
08.2021 - Current
- Lead group of 3 validation engineers by coordinating over 40 CTUs requalification activities in different sites of Moderna's Facilities to satisfy client's tight deadlines demands and project timelines.
- Generated validation documentation including User Requirement Specifications (URS), Impact Assessments (IAs), Design Qualification (DQs), Risk Assessments (RA), Supplier Protocol Assessments (SPAs), Installation and Operational Qualification protocols (IOQs), Acceptance and Release Reports (ARRs), and Release Forms (RECs).
- Developed and executed validation protocols for Control Temperature Units (CTUs) and manufacturing equipment (AxiChrom Columns, Nanodrop Spectrophotometer, SUMs, PH Meters, and Differential Pressure Transmitter sensors).
- Calibrated and verified thermocouples sensors in order to execute temperature mappings using validation equipment KAYE Validator AVS and Ellab ValSuite.
- Executed periodic reviews for manufacturing equipment such as SUMs, Solo VPEs, Biological Safety Cabinets, HPLC, UHPLC, Water Purification Systems, and Ultrafiltration Skids, across sites.
- Identified and solved issues related to KAYE Validator and Ellab ValSuite.
- Trained and assisted staff in validation techniques, methods and testing processes.
- Provided guidance, subject matter expertise, and support to validation engineers.
- Supported closing of Quality Events and CAPAs.
Test Method Validation Specialist
Fenwal Inc, Fresenius Kabi
09.2020 - 08.2021
- Generated and executed Test Method validation protocols per USP guidelines.
- Performed routine laboratory tests for raw materials, initial, in process, and final products according to current USP, EP, and internal SOPs.
- Routine operation and trouble shooting in HPLC, UV/VIS, pH meter, and Flame Photometer.
- Generated and entered test results for Initial, In process and Final chemical samples in BLIMS.
- Worked constructively across all functions of the organization as well as external customers in implementation of new labware software.
- Collaborated in laboratory investigations of non‐conformances, corrective and preventive actions.
- Developed and revised SOPs for laboratory equipment.
- Used quality tools and process techniques to improve laboratory processes to eliminate causes of non-conformities.
- Reviewed technical documentation.
- Trained and guided new personnel on laboratory equipment and chemical testing.
Chemist
PACE Analytical
03.2018 - 03.2019
- Worked on requalification for SKAN equipment.
- Executed ssDNA Installation and Operational Qualifications (IOQs) and provided support in cleanroom qualifications.
- Executed FTUs Addendum qualifications for 10 and 5 litters bag recipes.
- Provided support on FDA observation remediation protocol.
- Scheduled coordination of requalification for CTUs and periodic reviews for more than 600 FUSE equipment in all sites of Moderna facility.
- Actively involved in the coordination and logistic of Ellab equipment for validation teams in all sites of Moderna facility in order to meet requalification deadlines.
- Provided guidance, subject matter expertise, and support to validation engineers.
- Ensured that the validated state of the equipment is established in accordance with internal procedures, regulatory equipment, and industry standard.
- Executed CTUs temperature mappings and periodic reviews across sites.
- Met tight deadlines to satisfy client demands and project timelines.
Education
Bachelor of Science - Chemistry
Interamerican University
San German, PR07.2017
Minor - Biology
Interamerican University
San German07.2017
Skills
- Current Good Manufacturing Practices (cGMP)
- Highly experienced in troubleshooting of validation equipment KAYE Validator AVS and Ellab ValSuite
- Knowledge in Gas Chromatography , Gas Chromatography-Mass Spectrometry, High Performance Liquid Chromatography , UV-Vis Spectrophotometer, IR, and FIT-IR
- Knowledge in OSI PI System, Veeva, Blue Mountain Ram (BMRAM), and Kneat
- Proficient in Scigress, ChemSketch, GC Simulator, Microsoft office, Empower 3, BLims, POMS, and Lab Ware
- Proficient in MS Office (Word, Excel, and Power Point)
- Proficient in Smartsheet
- Fully Bilingual (English and Spanish)
Timeline
Moderna Therapeutics, Lead Validation Engineer
Escalate Life Sciences
01.2023 - Current
Moderna Therapeutics, Validation Engineer
Escalate Life Sciences
08.2021 - Current
Test Method Validation Specialist
Fenwal Inc, Fresenius Kabi
09.2020 - 08.2021
Chemist
PACE Analytical
03.2018 - 03.2019
Bachelor of Science - Chemistry
Interamerican University
Minor - Biology
Interamerican University
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