The Oral Solid Dose Value Stream TTS- Change Parts Focused is a liaison between the production work teams and other enabling support teams with the primary focus on all change parts management. Primarily the tableting tooling and blister packaging change parts.
Responsible for program to assure inspection, care, repair and availability of parts to meet the weekly production schedule. This includes communicating expectations to production work team including training, operational excellence systems development, preventative maintenance and repair of OSD formulation and packaging area change parts.
The job includes establishing and improving processes by using lean thinking and lean manufacturing applications for a three shift operation. The Change Parts TTS will initiate and lead efforts in root cause problem solving and implementation of effective corrective/preventative actions by using Lean tools such as: M1 problem solving, Zoetis Human Performance Analysis, Process FMEA, and systematic trouble shooting related to change parts.
The Change Parts TTS will demonstrate leadership through working with key enabling functions in Plant Engineering/Maintenance, Quality, Production Scheduling/Planning, Procurement, and Technical Services. The Change Parts TTS will also work alongside the production work teams to ensure that applicable safety guidelines/policies are followed and that all tasks are performed in accordance with appropriate processing standards such as FDA Good Manufacturing practices (GMP).
- Ensures that all cGMP requirements are met for all change parts procedures and logs
- Ensure all OSD change parts meet specifications for use
- Able to initiate and facilitate problem solving and training sessions for OSD change part care
- Coordinate and/or perform On the Job Training (OJT) related to all OSD change part cleaning, care and inspection
- Establish policies and procedures to further support effective management of all change parts and supporting systems
- Documentation tracking system for change part usage from purchase through end of useful life including actions of repair and point of destruction
- Continuous learning of OpEx programs, systems and tools
- Ensure that Equipment and Maintenance logs are accurate and complete relative to change parts
- Ensure that Operator Care and Calibration is performed to plan and documented accurately for all Tool Room equipment
- Lead/support implementation and validation of supporting equipment and systems relating to the change parts program
- Initiates and tracks green tags/work orders
- Knowledgeable with EBR PAS/X system and able to assist
- Responsible for issuing PO’s for purchase of all new change parts, repairs of change parts and consumable items for OSD
- Able to perform other duties as required
Required skills, education, and experience:
- High school diploma or general education degree (GED).
- Basic math and reading comprehension.
- Effective communication and demonstrated leadership abilities.
- Ability to follow detailed instructions.
- Strong mechanical abilities.
- Ability to operate, maintain, troubleshoot and make minor repairs on production equipment and/or tooling.
- Mechanical reasoning skills that will be essential for troubleshooting.
- Strong knowledge of GMPs and production practices.
- Ability to read and understand drawings / blueprints, utilizing this knowledge for the inspection / repair of equipment change parts and tooling.
- Demonstrated use of precision measuring devices and the ability to use shop tools. Ex. Grinder, buffer, polisher.
- Experience in Lean Manufacturing and continuous improvement work environment; 5S, visual schedule, PDCA, M1, etc.
- Ability to train on area SOP’s/OJT’s- equipment, process, paperwork
- Experience in working with Tech Writer creating and maintaining training documentation
- Experience in manufacturing Oral Solid Dose (OSD) i.e. Tablet products
- Experience in cleaning, set up, and troubleshooting of equipment; Tableting, and Blister Packaging.
- Knowledge of Windows based applications, Ariba-SAP and Laser Measurement Systems.
Physical and Time requirements
- Routine lifting of 20-50 lbs.
- Prolonged periods of standing.
- Flexible hours and overtime may be required.
- Expected to respond to off-hour phone calls.