Industrial Engineer II

The Industrial Engineer II uses engineering and continuous improvement techniques, establishes optimum manufacturing cell configuration (creation of the most efficient manufacturing cell from material inflow, through production, to outflow).  Leads process of systemization and standardization of product routings, process descriptions, material flow/usage and throughput rates within the vision of Lean Manufacturing.  Provides input for facility planning, plant layouts, and performs capacity studies to determine if plants are capable of filling customer orders and develops detailed plans/layouts to maximize process efficiencies and minimize space costs.  Performs other duties as necessary in support of business objectives.  

Specific Responsibilities

• Analyze and optimize manufacturing processes to improve efficiency, reduce waste, and ensure compliance with GMP standards.
• Lead or support lean manufacturing, Six Sigma, and other continuous improvement projects.
• Develop and maintain time studies, work instructions, standard operating procedures (SOPs), and value stream maps.
• Collaborate with cross-functional teams including Quality, Production, Supply Chain, and Maintenance to implement process improvements and resolve production issues.
• Support capacity planning, line balancing, and facility layout optimization.
• Monitor key performance indicators (KPIs) and provide regular reporting on operational performance and improvement metrics.
• Participate in root cause analysis and corrective/preventive action (CAPA) activities.
• Ensure engineering solutions and process changes are validated and documented in accordance with GMP and company procedures.
• Support new product introductions (NPIs) by assessing manufacturing requirements, developing workflows, and assisting in equipment selection and validation.
• Provide training and guidance to production staff on new or revised processes and best practices.
• Other duties as assigned.

General Responsibilities

• Poses no direct threat to the health or safety of himself/herself, of others, or property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation.  
• Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work. 
• Performs such individual assignments as management may direct.  
• Other duties as assigned. 

Education, Experience, and Licenses:

• Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, or a related field.
• 8+ years of experience in an industrial engineering role, preferably in a GMP-regulated manufacturing environment.

Knowledge, Skills, and Abilities

• Strong understanding of GMP, regulatory compliance, and quality assurance standards.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Knowledge of environmental, health, and safety (EHS) protocols.
• Proven track record in process optimization, cost reduction, and operational efficiency.
• Excellent leadership, organizational, and communication skills.
• Ability to manage complex projects and lead cross-functional teams.
• Proficiency in manufacturing software and systems.