Chief Process Optimization Specialist
1 week ago
Job Overview
">The Process Engineer plays a key role in optimizing manufacturing schedules, maintaining GMP compliance and cost efficiency. They manage process engineering activities including all planned and unplanned works on process equipment.
">Responsibilities:
">- Manage process engineering activities to meet and optimize manufacturing schedules while maintaining a high level of GMP compliance and cost efficiency.
- Coordinate with maintenance all utilities equipment activities including all planned and unplanned works on utility equipment associated with the clean areas.
- Provide training to the process and utility technicians on process equipment.
- Collaborate with the maintenance and utilities lead to optimize the preventative maintenance program across process and utility systems.
- Implement equipment and maintenance reliability improvements.
- Develop and implement area/equipment improvement plans to repeat failures and other maintenance problems.
- Life cycle management of the validation of qualified equipment and ongoing process engineering support for this equipment.
- Provide support to Manufacturing, Validation, and Maintenance on process equipment and utility systems when required.
- Manage all process engineering and validation activities associated with qualified equipment on site.
- Coordinate with quality and other areas on the requalification program.
- Manage vendors supporting/executing the works.
- Provide Engineering expertise in trouble shooting activities to support manufacturing during process transfer activities or deviation investigations.
- Support regulatory inspections.
- Lead and support system improvements, development of specifications, engineering documents and standard operating procedures.
- Identify and support process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing support equipment.
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