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Regulatory compliance, validation, quality systems & technology consulting for pharma, medical device & biotech. Founded 2005 in Puerto Rico.

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com / to learn more about our services and solutions!

We are seeking a Process Engineer to support automated manufacturing operations for a leading medical device manufacturer in North Carolina. This position will play a key role in maintaining equipment reliability, supporting production operations, troubleshooting process issues, and driving continuous improvement initiatives within a highly regulated manufacturing environment.

The selected candidate will provide technical and engineering support for automated filling, labeling, and formulation systems while collaborating with cross-functional teams to ensure safe, efficient, and compliant operations.

Essential Responsibilities

  • Support and execute scheduled preventive maintenance activities on automated manufacturing equipment.
  • Troubleshoot equipment and process-related issues to minimize downtime and maintain production schedules.
  • Provide technical support during line operation, including equipment adjustments and process optimization.
  • Assist with mechanical line changeovers and equipment setup activities.
  • Support spare parts management activities, including inventory monitoring and availability of critical components.
  • Investigate equipment failures and implement corrective and preventive actions.
  • Analyze equipment performance and identify opportunities for reliability and efficiency improvements.
  • Collaborate with Operations, Maintenance, Quality, and Engineering teams to resolve technical challenges.
  • Ensure all activities are conducted in compliance with safety, quality, and regulatory requirements.
  • Maintain accurate documentation of maintenance, troubleshooting, and improvement activities.

Equipment Experience Preferred

Experience supporting, maintaining, or troubleshooting the following equipment is desirable:

  • Shibuya Filling Systems
  • Optima Filling Systems
  • Groninger Filling Systems
  • Formulation Tank Farm Systems
  • Herma Labeling Equipment

Required Qualifications

  • Willing to work in North Carolina
  • Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Manufacturing Engineering, or related discipline.
  • Experience supporting automated manufacturing, packaging, filling, or production equipment.
  • Strong troubleshooting and root cause analysis skills.
  • Experience with preventive maintenance programs and equipment reliability practices.
  • Ability to work effectively in a fast-paced manufacturing environment.
  • Strong communication and problem-solving abilities.

Preferred Qualifications

  • Experience within the pharmaceutical, biotechnology, medical device, or life sciences industries.
  • Familiarity with GMP-regulated manufacturing environments.
  • Experience working with highly automated production systems.
  • Knowledge of spare parts management and inventory control.
  • Lean Manufacturing and/or Continuous Improvement experience.

All your information will be kept confidential according to EEO guidelines.

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