Manufacturing Process Improvement Specialist

1 week ago


North Chicago, Illinois, United States cGMP Consulting Inc Full time

Job Summary

We are seeking a highly skilled Senior Analyst, Manufacturing Process to join our team at cGMP Consulting Inc. The successful candidate will be responsible for managing production projects that aim to improve manufacturing efficiency and safety, reduce costs, minimize opportunities for human error, and enhance compliance.

Key Responsibilities

  • Utilize technical skills and knowledge to support production initiatives, execute systems and procedures efficiently, and evaluate systems for improvement potential.
  • Schedule work tasks to support project and campaign timelines, circulate documents for review, and manage document approval processes.
  • Analyze data to develop solutions to general-level problems, present potential solutions to management, and assist in implementation planning.
  • Assist in the execution of validation activities for manufacturing equipment, provide technical assistance, and troubleshoot equipment issues.
  • Establish requirements and assist in implementing changes to the Process Control System.
  • Investigate events in production that impact quality or compliance, lead or participate in RCPS or FMEA sessions, and document outcomes.
  • Transfer methods into production instructions, provide training, and ensure successful rollout of new methods.
  • Manage inventory and production tracking, serve as a subject matter expert in SAP, and interface with Planning to create and manage production process order numbers and batch numbers.

Requirements

  • Bachelor's Degree or equivalent in an engineering or related field, with at least 5 years of experience in manufacturing/production processes and good writing skills.
  • A working knowledge of safety, quality systems, and current Good Manufacturing Practices, as well as familiarity with pertinent regulatory filings.
  • Proficiency in tech transfer processes, equipment and facilities validation, and MS Office skills.

Working Environment

The ideal candidate will be flexible, able to handle multiple tasks, and work under pressure in a professional manner. They must effectively work in a team environment, maintain high energy and professionalism, and build effective working relationships with customers, co-workers, and management.



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