CONTINUOUS IMPROVEMENT ENGINEER at Formulated Solutions

Largo, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Jan, 26

Salary

0.0

Posted On

24 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Improvement, Lean Manufacturing, Six Sigma, GMP Compliance, Data Analysis, Project Management, Communication, Problem Solving, Training, Collaboration, Root Cause Analysis, Efficiency Enhancement, Cost Reduction, Quality Improvement, Statistical Tools, Process Optimization

Industry

Pharmaceutical Manufacturing

Description

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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Responsibilities

The Continuous Improvement Engineer will lead initiatives to streamline manufacturing processes and enhance overall efficiency while ensuring compliance with GMP standards. This role involves collaborating with cross-functional teams to implement Lean and Six Sigma methodologies for continuous operational improvement.