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The Fountain Group

Pharmaceutical Manufacturing Engineer

The Fountain Group, North Chicago, IL, United States


100% ONSITE North Chicago IL 60064

Pay: $33-$38/hr

REQUIRED:

Recent Graduate with a BS/MS in Engineering and Co-op/internship experience within a FDA regulated industry working with investigations, RCA and CAPAs.

Previous experience in manufacturing processes of biotechnological drugs, aseptic operations, parenteral drugs, solutions preparation, and sterilization operations preferable.

  • Knowledge in manufacturing equipment's troubleshooting.

  • Previous experience with Control Systems; Delta V and MES preferable.

Job Description:

Major Responsibilities

Comply with Corporate and Divisional policies and procedures, North Chicago Manufacturing Plant procedures, and regulatory agencies regulations and requirements.

Provide technical assistance to the manufacturing areas

Assist in the troubleshooting of the manufacturing equipment and process.

Investigate process and equipment exceptions and follow up CAPA implementation.

Revise SOP's and PCR and submit Change Requests (CR) for approval.

Develop and implement changes that will improve equipment performance and consequently product quality in the Manufacturing Areas =and reduce manufacturing costs.

Evaluate and implement new equipment technology.

Establish requirements and assist in the implementation of changes to the Process Control System.

Participate in the development and execution of validation protocols. Participate in the manufacturing personnel training.

Give direct support to the manufacturing process and trouble shootings.