Manufacturing Systems Engineer

Role Overview

This position will be responsible for ensuring the efficient design, optimization, and maintenance of manufacturing systems and processes to meet quality, safety, and regulatory standards. This role plays a key part in driving continuous improvement in production operations, working closely with cross-functional teams to enhance production efficiency, reduce costs, and maintain product quality.

What You Will Do

Design, optimize, and maintain manufacturing systems and processes, develop Process Development Studies, generate User Requirement Specification documents, manage capital projects, and ensure equipment compliance with established safety standards.

Why It Might Be a Fit

Must have a bachelor's degree in engineering, 1-3 years of experience in pharmaceutical manufacturing or a related industry, and exceptional technical writing and documentation skills.

Requirements

• Bachelor's degree in engineering
• 1-3 years of experience in pharmaceutical manufacturing or a related industry
• Exceptional technical writing and documentation skills
• Knowledge of validation processes in pharmaceutical manufacturing
• Familiarity with FDA regulations, GMP, and other regulatory requirements governing pharmaceutical manufacturing
• cGMP Pharmaceutical/Biotech experience
• Advanced proficiency in Microsoft Word
• Working knowledge of Microsoft Excel
• Highly organized with the ability to manage multiple projects and changing priorities
• Ability to successfully prioritize and manage large projects, deadlines, and tasks
• Effective verbal and written communication
• Ability to work independently while collaborating across teams
• Proficiency in mechanical design (Auto CAD and Solidworks) and troubleshooting
• Knowledge of PLC, Vision Systems, and equipment troubleshooting
• Six Sigma certification (greenbelt or blackbelt)
• Familiarity with the following processes: liquid dispense, sterile pathway, autoclave cycle development, leak detection, pick-n-place, printing/labeling

Benefits

• Valid driver's license or government issued ID
• Pass a drug test