The Manufacturing Engineer is responsible for providing technical assistance to the manufacturing areas related to the manufacturing process and equipment. Support troubleshooting in equipment malfunction or optimizations. 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.
- 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 troubleshooting. 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.
- Supports the batch record audit process and discrepancies closures.
- Provide support during Regulatory Agency Audits.
- Comply with Abbvie policies and procedures, Engineering Standards and Specifications, and regulatory agency regulations and requirements. Provide technical assistance to the manufacturing areas.
- Bachelors Degree in Engineering. Preferably in Chemical, Mechanical or Industrial Engineering concentration.
- At least two (2) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
- Previous experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant desired.
- Must demonstrate knowledge in manufacturing equipment troubleshooting.
- Previous experience in container filler for parenteral use, Automatic Machine for Visual Inspection, Washers, Autoclaves, Tanks, steam systems, CIP systems, bench instruments (Filter Integrity Testers, Density meters, pH meters, Osmometers) is strongly preferred.
- Previous experience with Control Systems; DeltaV and MES preferred.
- Knowledge of quality regulations and standards affecting chemical, biological or medical devices. knowledge of corporate, local, state, and OSHA regulations.
- Excellent verbal and written communication skills in both, English and Spanish.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced