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Alajuela

    Sr. Improver-Process - Alajuela, Costa Rica - CooperCompanies

    CooperCompanies
    CooperCompanies Alajuela, Costa Rica

    hace 1 hora

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    De jornada completa
    Descripción

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

    Essential Functions

    Accountable for:

  • 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

    • Assist in:

  • Supply Chain Performance Indicators Improvement
  • Unit RM Usage Optimization
  • Unit MRO, Incl. Spare Parts Usage Optimization
  • Quarterly Capex meeting with Projects and Owners Team
  • Defining Tactics for Quality First Pass, DPM & CPM Metric (Once a Year)
  • Quality Documentation Approval
  • Quality Awareness
  • Identifying and Implementing Corrective/ Preventive Actions
  • Preparing Rework Protocols or memos for NCRs
  • Investigating NCR, Quality Feedback and Complaint
  • Developing Actions to improve Quality KPI's
  • Developing Procedures for QI
  • Providing Training for QI
  • Providing Support for the QI Start-up
  • Defining and Prioritizing Process KPIs for improvement
  • Writing validation documentation (protocols)
  • Protocol Approval
  • Developing process and regulatory documentation for automation systems
  • Performing and documenting engineering studies
  • Early Involvement in Transference Effort with Technical Innovations (ROI)
  • Assuring Operator and BU's resources have the Skills and knowledge to receive the Product Transfer
  • Early Involvement in LS /Optimization Efforts with Technical Innovations (ROI)
  • Assuring Readiness of Manufacturing Requirements for the Optimization Efforts
  • Identifying possible causes of variation/ failure/ under equipment performance for Manufacturing.
  • Procedure Approval for skills certifications
  • Technical Academy design and delivery
  • Optimizing Unit Performance
  • Shutdown Planning and Execution

    • Active Participation:

  • Inserts Inventory Supplies
  • Unit MRO, Incl. Spare Parts Price Optimization Awareness
  • Unit MRO, Including Spare Parts Inventory Optimization
  • Plant RM & MRO Leverage Opportunities
  • Unit Capacity Utilization $'s
  • Cost Modeling for Process Improvement
  • Material Quality issues avoidance
  • Monitoring Supplier's Performance
  • Evaluating Quality Issues Reports at Manufacturing. & QA Final
  • Investigation (Data gathering of Quality issue)
  • Evaluating NCR Actions Effectiveness
  • Initiating Non-Conformance Resolution
  • Evaluating NCR
  • Leading Improvement Activities
  • Developing supporting Documentation for QI
  • Implementing Safety corrective actions
  • Safety Non-Conformance Resolution
  • Identifying process and/or Manufacturing equipment not performing as expected
  • Ensuring correct resources are acting upon situation for Manufacturing.
  • Designing and programming of Process automation improvement systems
  • Providing technical solutions that increase utilization and reduce costs.
  • Improving accuracy Automation System requirements and specifications for the development of SCADA and other systems
  • Reviewing/ Modifying Standard Operating Procedures for Engineering Controls
  • Final selection of resources
  • Test Design for skills Certifications
  • Preparing Training Module for skills certifications
  • Budget Development and Administration
  • Monitoring Unit Performance
  • People Development
  • Providing Capabilities to Work Unit
    • 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
    • Work Environment:
  • Generally, works in a closed environment, in office conditions, with moderate level of noise and controllable changes of temperature.
  • Needs to stand, walk, and may be seated for a long period of time.
  • Uses hands to feel, handle and reach.
  • Works with a personal computer and programs to prepare documents or reports.
  • Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others.
  • Needs to have high analytical capacity and level of professionalism and judgment to resolve problems.
  • May be exposed to fumes, gases, or strong odors (non-toxic)
    • Experience:
  • Six to ten years of experience with similar responsibilities in a regulated industry (medical devices/pharmaceutical highly desirable)
    • Education:
  • University bachelor's degree in engineering or Advanced Student in that fields (Industrial, Chemical, Mechanical, Electrical)
  • University master's degree in engineering (Industrial, Chemical, Mechanical, Electrical) preferred
    • Regulation Requirements Quality System Responsibilities
  • Complies with the Quality System Regulation (QSR)
  • Executes job responsibilities as established in the Standard Operating Procedures (SOP)
  • Follows the documentation procedures.
    • Safety & Occupational Health Responsibilities
  • Complies with Safety and Occupational Health Policy and procedures.
  • Complies with Hazardous Communication program.
  • Notifies immediately all accidents or incidents occurred in work area.
  • 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.
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