Hector Amaro Email & Phone Number

Las Piedras, Puerto Rico

Conducted validation of computerized systems as part of migrating over 40 servers during the McNeil to Kenvue transition, ensuring adherence to each phase's due dates. Generated and executed qualification protocols (IQ/OQ) for Manufacturing Execution System (MES) servers.

Medtronic, Juncos Pr

Worked in the packaging area for a new product launch, providing technical support to packaging activities of clinical builds. Completed nonconformance investigations for the packaging process. Performed an engineering assessment to identify the root cause of foreign material presence in devices during the packaging process. Designed a solution through root cause analysis and development of various prototypes, successfully decreasing the process cycle time by 90%.

Janssen Ortho Lcc, Gurabo, Pr

Created comprehensive validation documents, including assessments, plans, user and functional requirements, design specifications, traceability matrices, and reports. Generated and executed a range of qualification protocols (IQ/OQ/PQ) along with the necessary documentation.

Puerto Rico

Created three Process Operational Description (PODs) for setup and operation of production equipment as part of a project to implement a new manufacturing line.

Puerto Rico

•Created manufacturing batch record of clinical batch using research and development (R&D) protocol •Executed the manufacturing process of clinical batch (tablets) and shipped tablets to R&D plant•Supported plant development activities and eventual filling as Abbreviated New Drug Applications (ANDA)•Developed 2 standard operational procedures (SOPs) for the creation and modification of recipes in equipment•Provided security and control of product recipes and ensure compliance… Show more •Created manufacturing batch record of clinical batch using research and development (R&D) protocol •Executed the manufacturing process of clinical batch (tablets) and shipped tablets to R&D plant•Supported plant development activities and eventual filling as Abbreviated New Drug Applications (ANDA)•Developed 2 standard operational procedures (SOPs) for the creation and modification of recipes in equipment•Provided security and control of product recipes and ensure compliance with data integrity program•Managed a 2 week kaizen event in Pilot Plant laboratory with an operator and pharmaceutical specialist •Achieved Pilot Plant laboratory standardization obtaining Yellow Belt Certification Show less

Puerto Rico

•Performed a site water balance•Developed a water distribution diagram in Microsoft Visio •Identified 8% of water savings by correcting leakages and water recycle system

Puerto Rico

•Managed a team of 25 students maintain team motivated•Developed strategies, time schedules, and proposals •Coached team members during theory & concepts, design, analysis, and manufacturing process•Designed and manufactured mechanical vehicle parts with the required specifications in Solid Works•Created and led a team to develop the competition report•Managed a budget of $8,000 for materials, equipment, hotel and travel expenses•Founded new telemetry department in the… Show more •Managed a team of 25 students maintain team motivated•Developed strategies, time schedules, and proposals •Coached team members during theory & concepts, design, analysis, and manufacturing process•Designed and manufactured mechanical vehicle parts with the required specifications in Solid Works•Created and led a team to develop the competition report•Managed a budget of $8,000 for materials, equipment, hotel and travel expenses•Founded new telemetry department in the project obtaining real time data during competition•Won 1st report award and ranked #25 out of 46 international universities in overall competition Show less

Puerto Rico

•Performed weekly walk-throughs to update P&ID drawings and equipment information in GMARS Maximo•Coordinated equipment installation and gave follow-up to 2 projects•Upgraded preventive maintenance job plans for utilities equipment•Executed reliability engineer role developing new maintenance plan for chillers•Reduced chillers refrigerant leakage to comply with Environmental Protection Agency (EPA) regulations •Conducted a site steam consumption analysis to support energy… Show more •Performed weekly walk-throughs to update P&ID drawings and equipment information in GMARS Maximo•Coordinated equipment installation and gave follow-up to 2 projects•Upgraded preventive maintenance job plans for utilities equipment•Executed reliability engineer role developing new maintenance plan for chillers•Reduced chillers refrigerant leakage to comply with Environmental Protection Agency (EPA) regulations •Conducted a site steam consumption analysis to support energy savings project •Projected $200K estimated benefit in steam generation Show less