Will be responsible to provide technical support and improve processes to minimize cost, prepare projects plans to work with assigned task as documentation in coordination with the division and support department. Shall be capable to manage difficult Manufacturing processes problems through a well and sound solution methodology. Must be able to comprehend and fully apply new technology developments.
Review Manufacturing lines start up, operation, labeling, package, release, and shipping logistic for appropriate process flow and documentation. Review sterilization seal integrity pre and post as required per validation requirements.
Development and implementation of process improvements and optimization through statistical process control experiments designs.
Updates process sheets, specifications, bill of materials, drawing, operating procedures and any other documentation needed to manufacture, test or purchase products.
Assists in establish annual tooling and capital investment budgets, selects, propose and justify of less-experienced department personnel.
Assists in the training of less-experience departmental personnel.
Designs tools and/or machines of varying types (some of very complex nature) for use in the manufacturing of company products. Obtains approval and builds when required the necessary tooling for products.
Re-designs, repairs, or replace in-process production program equipment, production control hardware, and tooling.
Layout applicable departments to establish optimum material flow, space usage and work station layout.
Machine capability and utilization.
Develops processes, methods, tooling, and production controls for new programs; supervises their assembly and proofing.
Sets-up new equipment, ensure its satisfactory operation, and instructs others to use the new equipment properly.
Writes procedures for the operation of new or existing equipment.
Recommends incorporation of new technology for Company applications where feasible and practical.
Support and coordinate the implementation of the Lean Manufacturing Methodology.
Support and coordinate manufacturing lines relocation from one location to new locations.
Identify new opportunities for Process Improvement and implement Process Control Metrology.
Identify and eliminate the Non Value Added Activities in coordination with the Division and support departments.
Identify new innovation methods and submit capital request for budgeting and improvement purposes.
Develop design of experiments whenever an equipment or process improvement is required and define new set up parameters and process limits to establish requirements per Corporate Guidelines.
Value analysis of product and methods with emphasis on cost reduction of labor, material, and auxiliary expenditures.
Plans, writes, coordinates, executes, summarize validation protocols: transfer plan validation, risk assessments, Installation Qualifications, Operation Qualifications, Performance Qualification, Results obtains approvals.
Project planning and executing.
Motivates, manages and develops personnel in a team environmental.
Assures is trained before performing any task
Uses the required clothes, personal and security protective equipment according to operations requirements
Complies with the cGMP’s, Quality Standards and established policies and/or procedures
Executes other duties assigned by the supervisor
- BS Degree in Engineering, preferably in Chemical, Industrial or Mechanical Engineering.
- Five (5) or more years of experience as a Manufacturing Engineer, preferably with tool and machine design experience in the Pharmaceutical and/or Medical Devices manufacturing environment.
- Experience in capital appropriation evaluation and analysis.
- Strong background in statistical Process Control.
- Must be bilingual (English and Spanish) and must have good Communication skills both oral and written.
- Must have knowledge of CMP’s, OSHA, and ISO 9000 requirements and Continuous Process Improvement techniques.
- Strong knowledge and experience in packaging method such as heat sealing, thermoforming and thermoplastic.
- Must have knowledge in Qumas, Microsoft Projects Planning, FMEAS, HACCP and validation preparation and documentation (master protocol, risk assessment, IQ, OQ, and PQ)
- C. Literate.
- Excellent analytical, organizational, interpersonal, written, and verbal communications skills.