Senior Process Improver
CooperVision
Costa Rica
hace 3 días

JOB SUMMARY

Continuously improves the performance of existing manufacturing processes and equipment through a structured approach.

ESSENTIAL FUNCTIONS

  • Coordinating production improvements implementation.
  • Creating troubleshooting guidelines and / or applicable SOPs and equipment maintenance and repair.
  • Identifying possible causes of variation / failure / under performance for Manufacturing.
  • Document diagnostics, solution method and impact in troubleshooting for Manufacturing.
  • Measuring Process KPIs for improvement.
  • Analyzing through a structured approach to identify root causes.
  • Improving Process KPIs performance.
  • Developing control mechanism to ensure Process KPIs consistency.
  • Designing and Coordinating Engineering Tests / Q's.
  • Executing Engineering Tests / Q's.
  • Documenting and Reporting Results of Engineering Tests / Q's.
  • Assuring Readiness of Manufacturing Requirements for the Product Transfer.
  • Receiving and Implementing Product and Equipment Transfer.
  • Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer.
  • Assuring Operator and BU's resources have the Skills and knowledge coming from change due to Optimizations.
  • Implementation of Optimization Efforts.
  • Defining manufacturing equipment maintenance requirements.
  • Developing TPM / PM / PDM procedures for manufacturing Equipment.
  • Verifying TPM / PM / PDM tasks effectiveness in manufacturing.
  • Ensuring correct resources are acting upon situation for Equipment Repair.
  • Correcting troubles in Manufacturing under performance situation using troubleshooting guidelines
  • and / or applicable SOPs.

  • Measuring Equipment Efficiency.
  • Identifying Opportunities for Improvements in Equipment Performance.
  • Implementing Equipment Upgrades and Optimization Changes.
  • Writing Validation Documentation and Test Protocols.
  • Documenting all Equipment Changes.
  • Assuring Compliance with Laws & Regulations.
  • Generation of Purchases Requisition.
  • Submitting Scope and Approve Projects.
  • Submitting Documentation for Safety Compliance, New Equipment Calibrations, Calibration extensions and Preventive Maintenance.
  • Systems & Equipment PM's SOP's Revisions / Improvements.
  • Evaluating Needs for Infrastructure Projects and Start-ups.
  • Submitting MSDS as Required.
  • POSITION QUALIFICATIONS

    KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of FDA current GMP / QSR regulation.
  • Excellent oral and written communication skills in both English and Spanish languages.
  • Teamwork and service oriented.
  • Effective leadership.
  • Computer literate (PowerPoint, Word, Excel).
  • Willing to travel.
  • Excellent interpersonal skills.
  • Highly motivated, self-starter, and responsible person.
  • Complies with the Quality System Regulation (QSR).
  • Executes job responsibilities as established in the Standard Operating Procedures (SOP).
  • Follows the documentation procedures.
  • Looks for ways to improve and promote quality.
  • Applies feedback to improve and promote quality.
  • Complies with Safety and Occupational Health Policy and procedures.
  • Complies with Hazardous Communication program.
  • Notifies immediately all accidents or incidents occurred in work area.
  • Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.
  • Promotes and maintains a safe working area and notifies any condition he / she may think might cause an accident.
  • Participates in the activities of the Safety and Occupational Health Program as requested.
  • EDUCATION

  • Bachelor degree in Engineering (, Electrical)Electromechanical, Mechanical. Master, preferred.
  • EXPERIENCE

    Six to ten years of experience with similar responsibilities in a regulated industry (medical devices / pharmaceutical highly desirable).

    CooperVision®, Inc. is an EEO / AA Employer M / F / D / V

    Inscribirse
    Inscribirse
    Mi Correo Electrónico
    Al hacer clic en la opción "Continuar", usted acepta que neuvoo recolecta y procesa su dirección de correo electrónico y las palabras clave utilizadas. Esta información será utilizada para suscribirlo a nuestras alertas de correo, de conformidad con lo establecido en nuestra Política de privacidad . Usted podrá darse de baja o retirar su autorización en cualquier momento con tan solo seguir estos pasos .
    Continuar
    Formulario de postulación