Manufacturing Controls Specialist

6 days ago


Scarborough, Maine, United States Intellectt Inc Full time
Job Title: Manufacturing Controls Engineer

Location: Scarborough, Maine

Job Summary:

We are seeking a highly skilled Manufacturing Controls Engineer to join our team at Intellectt Inc. The successful candidate will be responsible for designing, developing, and implementing manufacturing control systems to improve efficiency, productivity, and quality.

Key Responsibilities:

  • Develop and implement process development, equipment specification, acquisition, and implementation plans.
  • Evaluate machine logic and controls to troubleshoot equipment and identify process improvement opportunities.
  • Support on-site production and maintenance activities with advanced logic troubleshooting abilities.
  • Serve as a steward of the internal QMS management system for change management (Oracle's Agile PLM).
  • Integrate controls hardware and software into new and existing manufacturing equipment.
  • Design of experiments, validation, completion of testing, and analysis of data.
  • Suggest and support new methods or materials for continual improvement of quality and efficiency.
  • Analyze current equipment for process suitability and provide detailed plans for improvement.
  • Create and revise manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures to ensure compliant, efficient, and safe procedures.
  • Work with other engineers and technicians in developing solutions and improvements in materials, equipment, and process as necessary.
  • Actively participate in teams as necessary to ensure continual improvement, safety, and compliance.

Requirements:

  • Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
  • Minimum 3 years engineering experience in a manufacturing environment.
  • Experience working in a GMP, FDA, ISO, and USDA regulated environment preferred.
  • Previous experience with common manufacturing automation technologies and architectures is required.

Preferred Qualifications:

  • Experience working in a GMP, FDA, ISO, and USDA regulated environment.
  • Familiarity with cGMP and ISO 13485 regulations and practices.
  • Familiarity with statistical analysis software (Minitab).


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