Manufacturing Engineer

Summary:

The Manufacturing Engineer will play a crucial role in the design, optimization, and troubleshooting of manufacturing processes to ensure efficient, safe, and high-quality production of pharmaceutical products. This position requires hands on trouble shooting of electromechanical packaging equipment. This position involves close collaboration with cross-functional teams to support process improvement, compliance with regulatory requirements, and continuous improvement in a highly regulated environment.

Key Responsibilities:

• Process Optimization: Design, develop, and implement processes to improve manufacturing efficiency, reduce waste, and enhance product quality. Troubleshoot and resolve production issues to minimize downtime and ensure smooth operations.
• Equipment and Technology Management: Evaluate, select, and oversee the installation and maintenance of manufacturing equipment, ensuring they are functioning according to specifications and industry standards.
• Compliance and Documentation: Ensure all manufacturing activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards. Maintain accurate records, reports, and documentation in accordance with regulatory guidelines.
• Author technical documents such as Change Controls and WRKI’s, Review MPR’s etc.
• Quality Control and Assurance: Collaborate with quality assurance teams to identify and implement corrective actions, conduct root cause analysis for quality issues, and ensure continuous product quality in the production process.
• Project Management: Lead or participate in cross-functional teams for process improvement, facility upgrades, or new product introduction projects. Provide technical guidance on new product development and scale-up processes.
• Training and Support: Train and mentor operators and technicians on new processes, equipment, and safety procedures to ensure effective and efficient production workflows.
• Continuous Improvement: Identify opportunities for process automation, cost reduction, and other performance improvements. Foster a culture of continuous improvement using Lean, Six Sigma, or similar methodologies.
• Troubleshooting: Provide engineering support during production to resolve mechanical, electrical, or process-related problems in a timely manner.
• Safety and Risk Management: Promote a safe working environment by adhering to health and safety protocols and identifying any potential risks or hazards in the manufacturing processes.
  
  

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering, or a related field. (Degree in progress will be considered)
• 3 years of experience in a manufacturing engineering role, preferably within the pharmaceutical or life sciences industry.
• Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements (FDA, GMP, etc.).
• Experience with process design, process control, and equipment validation in a regulated manufacturing environment.
• Proficiency in the use of engineering software, such as AutoCAD, SolidWorks, or process simulation tools.
• Familiarity with Lean Manufacturing, Six Sigma, or similar continuous improvement methodologies.
• Excellent problem-solving, analytical, and troubleshooting skills.
• Strong communication and collaboration skills with the ability to work across cross-functional teams.
• Knowledge of statistical process control (SPC), root cause analysis, and design of experiments (DOE) is a plus.
  
  

Preferred Qualifications:

• Experience in process validation and equipment qualification (IQ/OQ/PQ).
• Familiarity with automation systems and manufacturing execution systems (MES).
• Certification in Lean or Six Sigma methodologies.
  
  

Physical Requirements:

• Ability to work in a cleanroom environment and follow strict hygiene protocols.
• Ability to lift up to 25 lbs. and perform tasks that may require standing, walking, or bending for extended periods.
  
  

Supervisory Responsibilities

Supervision of outside contractors, including OEM technicians, specialists and facility contractors where necessary.

DRESS CODE: This position will require business casual dress, along with company provided uniforms. The uniforms will be required when production support activities are the primary focus for the day/based on company needs.