The Manufacturing Engineer is responsible of providing technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment and controls. The position requires dealing with difficult technical problems in a highly technical and regulated environment. This position requires developing and implementing changes that will improve equipment performance and consequently product quality in the manufacturing areas and reduce manufacturing costs, maintaining a constant product turnover. Develop and modify procedures as needed to support the manufacturing operation. Participate in process, equipment, and facilities validation efforts and project implementations. Investigate process exceptions or equipment malfunction incidents affecting the process. Maintain the manufacturing area equipment in compliance with the calibration and maintenance programs.

Responsibilities

• Comply with Abbvie policies and procedures, Engineering Standards and Specifications, and regulatory agency regulations and requirements. Provide technical assistance to the manufacturing areas.
• Assist in the troubleshooting of manufacturing equipment and processes. 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.
• Initiate capital project ideas dealing with safety, quality improvement, capacity increase, and/or cost reduction. 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 manufacturing personnel training.
• Give direct support to the manufacturing process and trouble shootings. Provide assistance to operations in the control, management and disposal of household wastes, biomedical and hazardous to their respective area as applicable, ensuring compliance with federal and local regulations and policies following plant, division and corporate procedures.
• Provide support to supervisors in the batch record audit process and discrepancies closures.
• Provide assistance during Regulatory Agency Audits.