Manufacturing Process Engineer

1 week ago

Round Lake, United States Sterling Engineering Full time

Job Title: Manufacturing Process Engineer (Aseptic)

Location: Round Lake, IL

Hire Type: Onsite, Long-Term Contract (with full employee benefits)

Target Pay Range: $50.00 - $60.00/hour (W2)


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. This role will involve designing and implementing solutions to enhance efficiency, reduce downtime, and support continuous improvement efforts in sterile environments including utilities and production lines.


Job Duties:

  • 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.


Qualifications:

  • 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.

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