Lead Process Enhancement Engineer

hace 2 meses

Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

As a Senior Process Improvement Specialist, you will play a crucial role in enhancing the efficiency of our manufacturing operations through systematic methodologies.

Key Responsibilities:

  • Oversee the implementation of production enhancement initiatives.
  • Develop troubleshooting protocols and relevant Standard Operating Procedures (SOPs) for equipment maintenance and repair.
  • Identify root causes of variations, failures, or underperformance in manufacturing processes.
  • Document diagnostic processes, solutions, and their impacts on manufacturing troubleshooting.
  • Measure and analyze Process Key Performance Indicators (KPIs) to drive improvements.
  • Utilize structured analysis to pinpoint underlying issues.
  • Enhance the performance of Process KPIs.
  • Create control mechanisms to maintain consistency in Process KPIs.
  • Design and coordinate engineering tests and quality assessments.
  • Execute engineering tests and document the results comprehensively.
  • Ensure manufacturing readiness for product transfers.
  • Facilitate the transfer of products and equipment.
  • Observe and recommend actions for the initiation of product transfers.
  • Ensure that operators and business units possess the necessary skills and knowledge resulting from optimizations.
  • Implement optimization strategies effectively.
  • Define maintenance requirements for manufacturing equipment.
  • Develop Total Productive Maintenance (TPM), Preventive Maintenance (PM), and Predictive Maintenance (PDM) procedures.
  • Evaluate the effectiveness of TPM, PM, and PDM tasks in manufacturing.
  • Ensure appropriate resources are allocated for equipment repairs.
  • Address manufacturing underperformance issues using established troubleshooting guidelines and SOPs.
  • Measure equipment efficiency and identify opportunities for performance enhancements.
  • Implement upgrades and optimization changes for equipment.
  • Prepare validation documentation and testing protocols.
  • Document all modifications to equipment.
  • Ensure compliance with relevant laws and regulations.
  • Generate purchase requisitions as needed.
  • Submit project scopes for approval.
  • Provide documentation for safety compliance, equipment calibrations, and preventive maintenance.
  • Revise and improve systems and equipment PM SOPs.
  • Assess needs for infrastructure projects and start-ups.
  • Submit Material Safety Data Sheets (MSDS) as required.

Support Responsibilities:

  • Enhance supply chain performance indicators.
  • Optimize raw material usage at the unit level.
  • Improve maintenance, repair, and operations (MRO) and spare parts usage.
  • Participate in quarterly capital expenditure meetings with project teams.
  • Define strategies for quality metrics improvement.
  • Approve quality documentation and promote quality awareness.
  • Identify and implement corrective and preventive actions.
  • Prepare rework protocols for non-conformance reports (NCRs).
  • Investigate NCRs and quality feedback.
  • Develop actions to enhance quality KPIs.
  • Create and provide training for quality improvement initiatives.
  • Define and prioritize process KPIs for enhancement.
  • Document engineering studies and regulatory processes.
  • Engage early in product transfer efforts with technical innovations.
  • Ensure readiness of manufacturing requirements for optimization efforts.
  • Identify potential causes of equipment performance issues.
  • Design and deliver technical training programs.
  • Optimize unit performance and plan for shutdowns.

Active Participation:

  • Manage inventory supplies effectively.
  • Optimize spare parts pricing and inventory.
  • Leverage opportunities for raw materials and MRO.
  • Monitor unit capacity utilization.
  • Model costs for process improvements.
  • Avoid material quality issues through proactive measures.
  • Evaluate supplier performance.
  • Investigate quality issue reports in manufacturing and quality assurance.
  • Lead improvement initiatives and document supporting materials.
  • Implement safety corrective actions and resolve safety non-conformance issues.
  • Identify and address underperforming processes and equipment.
  • Design and program process automation improvement systems.
  • Provide technical solutions to enhance utilization and reduce costs.
  • Improve accuracy in automation system requirements for SCADA and other systems.
  • Review and modify standard operating procedures for engineering controls.
  • Prepare training modules for skills certifications.
  • Monitor unit performance and support people development initiatives.

Qualifications:

  • Six to ten years of experience in a regulated industry, preferably in medical devices or pharmaceuticals.
  • Bachelor's degree in engineering or advanced studies in Industrial, Chemical, Mechanical, or Electrical Engineering.
  • Master's degree in engineering is preferred.

Work Environment:

  • Typically works in an office environment with moderate noise levels and temperature control.
  • May require standing, walking, or sitting for extended periods.
  • Utilizes hands for various tasks and operates a personal computer.
  • Requires strong analytical skills and professionalism to resolve issues.
  • May be exposed to non-toxic fumes or odors.

Regulatory Compliance:

  • Adheres to Quality System Regulations (QSR) and follows established SOPs.
  • Complies with safety and occupational health policies.
  • Participates in safety programs and promptly reports incidents.

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