Advanced Manufacturing Optimization Expert

hace 2 meses

Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

As a Senior Process Improvement Specialist, you will play a pivotal 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 standard operating procedures (SOPs) for equipment maintenance and repair.
  • Analyze and identify root causes of variations, failures, and underperformance in manufacturing processes.
  • Document diagnostic processes, solutions, and their impacts on manufacturing operations.
  • Measure and evaluate Process Key Performance Indicators (KPIs) to drive improvements.
  • Conduct structured analyses to uncover underlying issues affecting performance.
  • Enhance the performance of Process KPIs through targeted strategies.
  • 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 analyze product transfer processes, providing recommendations for improvements.
  • Ensure that operators and business units possess the necessary skills and knowledge following optimizations.
  • Implement optimization initiatives effectively.
  • Define maintenance requirements for manufacturing equipment.
  • Develop and verify Total Productive Maintenance (TPM), Preventive Maintenance (PM), and Predictive Maintenance (PDM) procedures.
  • Ensure the effectiveness of maintenance tasks within manufacturing.
  • Address manufacturing performance issues using established troubleshooting guidelines and SOPs.
  • Measure equipment efficiency and identify opportunities for enhancement.
  • Implement upgrades and optimization changes to equipment.
  • Prepare validation documentation and testing protocols.
  • Document all changes made to equipment.
  • Ensure compliance with relevant laws and regulations.
  • Generate purchase requisitions as needed.
  • Submit project scopes for approval.
  • Provide documentation for safety compliance and maintenance activities.
  • Evaluate infrastructure project needs and start-up requirements.
  • Assist in improving supply chain performance indicators.
  • Optimize raw material usage and maintenance, repair, and operations (MRO) processes.
  • Participate in quarterly capital expenditure meetings with project teams.
  • Define strategies for quality metrics and documentation approval.
  • Identify and implement corrective and preventive actions.
  • Prepare rework protocols for non-conformance reports (NCRs).
  • Investigate quality feedback and complaints.
  • Develop actions to enhance quality KPIs.
  • Provide training and support for quality initiatives.
  • Write and approve validation documentation.
  • Engage in early involvement in product transfer and optimization efforts.
  • Identify and address equipment performance issues.
  • Ensure a safe working environment and comply with safety policies.

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 related fields (Industrial, Chemical, Mechanical, Electrical).
  • Master's degree in engineering preferred.
  • Knowledge of FDA current Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).
  • Excellent communication skills in English and Spanish.
  • Strong leadership and teamwork abilities.
  • Proficient in Microsoft Office Suite (PowerPoint, Word, Excel).
  • Willingness to travel as required.
  • High analytical capacity and professionalism.

This role is essential in driving continuous improvement within our manufacturing processes, ensuring we meet the highest standards of quality and efficiency.

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