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Manufacturing Process Engineer

1 month ago

Round Lake Beach, Illinois, United States Sterling Engineering Full time
Job Title:

Manufacturing Process Engineer - Aseptic Systems Specialist

Job Summary:
We are seeking a skilled Process Engineer with strong experience in aseptic manufacturing to support the Engineering & Maintenance department of a global medical device manufacturing company. The successful candidate will be responsible for optimizing and improving operational processes related to the facility's aseptic systems and maintenance activities.

Key Responsibilities:
  • Analyze and assess existing aseptic manufacturing processes and identify areas for improvement in sterility, efficiency, and reliability.
  • Implement and oversee process changes to enhance the performance of aseptic systems, including cleanrooms, utilities, and sterile production environments.
  • Lead and support engineering projects focused on maintaining and improving sterile manufacturing standards, ensuring timely project completion, budget adherence, and alignment with company operational goals.
  • Collaborate with the maintenance team to optimize preventive maintenance plans for aseptic equipment, troubleshoot equipment failures, and minimize downtime in sterile environments.
  • Collect and analyze data on aseptic operations and engineering performance, supporting decision-making and long-term process improvements while ensuring strict adherence to cGMP (current Good Manufacturing Practices).
  • Ensure all process engineering activities comply with aseptic manufacturing regulations, safety standards, and best practices, including ISO standards, FDA guidelines, and OSHA requirements.
  • Collaborate with cross-functional teams in engineering, production, and quality to drive continuous improvements in aseptic operations and facility systems.
  • Support sustainability and energy efficiency initiatives within sterile environments to reduce resource consumption without compromising product safety or quality.

Requirements:
  • Bachelor's Degree in Engineering (Mechanical, Chemical, or Industrial preferred) or related field.
  • 3-5 years of process engineering experience, with a focus on aseptic manufacturing or sterile environments.
  • Expertise in optimizing and managing aseptic systems, such as cleanrooms, HVAC, and utilities within pharmaceutical or sterile production facilities.
  • Experience leading projects related to aseptic manufacturing, from concept to execution, including coordination with cross-functional teams.
  • Experience in the medical device industry is preferred.
  • Experience with downstream manufacturing processes.

About Sterling Engineering:
Sterling Engineering is a global leader in medical device manufacturing, committed to delivering high-quality products and exceptional customer service. We are a dynamic and innovative company that values teamwork, collaboration, and continuous improvement.