Alberto Acosta Email & Phone Number

Chihuahua, Mexico

Juárez, Chihuahua, México

Juárez, Chihuahua, México

Chihuahua Y Alrededores, México

Since the acquisition of Cordis Corp. (now Cardinal Health), I have been working on research planning and elaborating transferring plans.Budget administration, overview and planning of the project transfer activities.Research includes.Gap Analysis of equipment and validation.Process Validation Strategies for New and existing manufacturing lines.Complete overview of the activities to be performed for transferring purposes and the installation of new lines at new manufacturing site (IQ, TMV, OQ, DOE, PQ, etc).

Chihuahua Y Alrededores, México

Main responsibilities as a CIP Engineer:• Identify process improvement opportunities. • Waste reduction through scrap analysis.• Supplier change validations (for manufacturing materials or components).• Work along RA to created FDA submissions (30 days notice).• Build business cases for projects using financial analysis.

Chihuahua Y Alrededores, México

Main responsibilities as a Project Leader:• To create documentation for manufacturing and packaging processes.• To define criteria to run IQ, OQ & PQ (CTQ's, KPOV's, AQL's, and DOE design).• To define material requirements for validation processes such as raw materials & Finished Goods.• To coordinate activities, production runs and train personnel in processes.• As the validation goes through it is necessary to define criteria to run IQ, OQ & PQ (CTQ's, KPOV's, AQL's, and DOE design).• Direct contact with suppliers to define requirements for machinery and raw materials.• Knowledge of workflow for Engineering Change Orders, Deviations and CDP’s.• To conduct Technical Design Review meetings.Main responsibilities as a Project Engineer:• Modification of BOM’s and FG drawings, as well as process instructions for manufacturing equipment and processes to be in compliance with current GMP's, ISO and FDA. • Part of the rebranding project (UDI TEAM) and Project Leader for the implementation of new Bell-Mark printing systems for Multivac FFS packaging machines and LVS Integra Barcode Quality Stations. • Design of labels for thermal printing systems using Easy Label Software (labels compliant whit ISO/IEC 15416 (linear barcodes) and/or ISO/IEC 15415 (2-D data matrixes).• DOE's for Bell-Mark Easy Print MLP Thermal Printing systems & Packaging Machines (BOSH-DOBOY).• Knowledge of ISO 11607 Parts 1&2 regulations for packaging of medical devices.

Cd. Juarez

• Knowledge of ASME drafting methods and standards.• Design of Experiments (DOE´s).• Knowledge in validation processes and procedures (IQ, OQ, PQ, DOE, CTQ's, KPOV's)Main responsibilities as a Manufacturing Engineer:• Development, modification of process instructions for manufacturing equipment and processes to be in compliance with current GMP's and the FDA. • Develop prototype procedures to operate new equipment or to introduce new methods.• Design of fixtures and drawings according to current drafting standards.• Process improvement.• Line balancing.• Cost reductions projects.• To maintain equipment and tooling in compliance with Security and quality.• To diagnose and find root cause of process issues and contribute with solutions to mitigate (contention action) and / or eliminate (corrective actions) the problem.• To coordinate activities, train personnel in new process/procedures.• Modification of procedures, documentation forms & drawings as required per derivables of the validation process through Agile.• To be part of CAPA, KAIZEN teams.

Cd. Juarez

Definir y controlar rutas de componentes.Balanceo de líneas.Distribución de materiales en SMK y MFG.Sistema SAP.Control de Inventarios.Recepción y pago de materiales, materia prima y componentes.Monitoreo de transportistas y control de entradas/salidas.Seguimiento a materiales críticos.Análisis de cuentas pagadas (resolución a proveedores).

Master Of Business Administration (Mba), Quality And Productivity

Bachelor Of Engineering (B.E.), Industrial Engineering

Mechatronics, Robotics, And Automation Engineering