Emilio Ramirez Email & Phone Number

Mexico

Tijuana, Baja California, Mexico

Tijuana, Baja California, Mexico

Developing the transfer of 5 new SKU’s from US to Mexico catalog, according ISO 13485 and FDA guidelines. Validation of machinery/process (IQ, OQ, PQ) since protocol writing, execution, and report closure.Coordinate trainings and evaluations with external/internal suppliers.Leading of multidisciplinary team for support activities.Communication/follow up with external departments as packaging, R&D, Regulatory, etc.Working with external packaging team to develop the packaging of new transferred product.Host of regular meetings to track progress based on planned objectives.Evaluation of potential risks, scalation, budget management for acquisitions.Experience on Rotary Convertion Press by rotative cutting dies and Urania Sealers.

Tijuana, Baja California, Mexico

Purchase of machinery, fixtures and process furniture.Creation of full documentation for new equipment as maintenance procedures, manufacturnig instructions, comply with EHS requirements and BOM's creation.Validation of equiment (IQ, ETE, OQ, PQ).Collaboration with multidisciplinary team to get support for validation activities, introduction of new equipment, etc.Experience on Multivac machinery for thermoformed vinil- tyvek packaging.

Tijuana, Baja California, Mexico

Maintain machinery spare parts on stock, design of tools and obsolete spare parts by reverse engineering using Solidworks.Support on Validations Process as IQ, OQ, PQ, ETE, TMV.Leadership of technician team, schedule of shifts and over-time, management of maintenance software to ensure maintenance and machinery Information is updated.Experience on Emplex band sealers and semiautomatic equipment.

Tijuana, Baja California, Mexico

Engineering change orders, facility layout updates in AutoCAD, creation and update of risk documents, participation in root cause analysis.Validation and re-validation of facilities equipment.Maintain facilities procedures updated.Experience on HVAC, Compressed Air and Vacuum equipment as well CME's rooms.