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Continuous Improvement Engineer
Continuous Improvement EngineerFormulated Solutions • Largo, FL, United States
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Continuous Improvement Engineer

Continuous Improvement Engineer

Formulated Solutions • Largo, FL, United States
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THE COMPANY :

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE :

We are seeking a highly skilled and driven Process Engineer with expertise in driving continuous improvement and Lean principles in a GMP manufacturing environment. The ideal candidate will have a strong background in process optimization, efficiency enhancement, and the implementation of Lean tools to improve overall operational performance while ensuring strict adherence to regulatory and quality standards. This is a key role aimed at ensuring the continuous enhancement of operations processes, driving cost reduction, improving quality, and maximizing productivity.

MAJOR DUTIES AND RESPONSIBILITIES :

Process Improvement & Optimization :

  • Lead continuous improvement initiatives to streamline manufacturing processes, eliminate waste, and enhance overall process efficiency.
  • Analyze current production processes to identify opportunities for optimization using Lean and Six Sigma methodologies.
  • Collaborate with cross-functional teams to implement improvements, ensuring the changes align with production goals and regulatory requirements.

Lean & Six Sigma Implementation :

  • Apply Lean tools such as Value Stream Mapping, 5S, Kaizen, TPM (Total Productive Maintenance), and other Lean methodologies to drive operational excellence.
  • Lead process improvement projects using DMAIC (Define, Measure, Analyze, Improve, Control) or DMADV (Define, Measure, Analyze, Design, Verify) approaches, focusing on improving quality, reducing costs, and increasing throughput.
  • Strong problem solving skills including use of SIPOC, 5-Why’s, Ishikawa diagrams, 8D and A3 advanced problem solving for root cause analysis (RCA).
  • GMP Compliance :

  • Ensure that all process improvements are implemented in full compliance with GMP guidelines and other regulatory requirements.
  • Maintain up-to-date knowledge of GMP regulations and standards to ensure manufacturing processes are always in compliance.
  • Data-Driven Decision Making :

  • Collect and analyze process data to monitor and evaluate key performance indicators (KPIs), identifying trends and areas for improvement.
  • Strong statistics foundation including us of Pareto analyses, SPC and basic Cpk analysis
  • Develop and maintain metrics for tracking the success of process improvements, presenting results and recommendations to management.
  • Training & Development :

  • Train and mentor production teams on Lean principles, problem-solving techniques, and process improvement methodologies.
  • Develop and deliver training programs to ensure all team members understand and can implement continuous improvement practices effectively.
  • Collaboration & Support :

  • Work closely with engineering, operations, quality, and maintenance teams to ensure successful project implementation and sustained improvements.
  • Provide technical guidance and troubleshooting support to resolve complex process-related issues in a timely manner.
  • Other duties as assigned.

    QUALIFICATIONS : Required

  • Bachelor’s degree in Engineering or related field.
  • 3-5 years of experience in process engineering, specifically within a GMP-regulated manufacturing environment.
  • Strong expertise in Lean manufacturing principles (5S, Kaizen, VSM, etc.) and Six Sigma methodologies (Black Belt, Green Belt, or equivalent).
  • Proven track record of leading continuous improvement initiatives in a manufacturing environment.
  • Strong analytical skills, with experience using statistical tools and process modeling software.
  • Excellent project management skills with the ability to manage multiple initiatives concurrently.
  • Strong communication and interpersonal skills with the ability to collaborate effectively at all levels of the organization.
  • Ability to work independently and make data-driven decisions.
  • Preferred :

  • Six Sigma certification (Green Belt, Black Belt).
  • Experience in pharmaceutical or biotechnology manufacturing environments.
  • Experience in training teams on Lean methodologies and process improvements.
  • Experience with Hoshin Kanri or Strategy Deployment processes
  • PHYSICAL / ENVIRONMENTAL DEMANDS : The amount of work and physical effort required to perform the duties of your job in a highly demanding manufacturing environment.

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