Job Title:  Operator I

Position Summary

Responsible for processing Customer product under their care, custody and control, utilizing industrial sterilization modalities in a highly regulated FDA, ISO and GMP environment. Responsible for the safe operation of processing equipment in accordance with all (Federal and State) operating regulations and procedures. Reviews and adheres to Customer provided work instructions and processing documents. Engages and embraces in Continuous Improvement, Lean, Quality, and Safety Initiatives. Depending on the modality in which this role operates (i.e. Gamma), this is a highly physical role – requiring strength and endurance.

Duties

Operational Excellence (100%)
1. Protects Customer product by assuring proper processing and handling according to operating procedures, Customer, quality, regulatory and internal company specifications; reviews and completes all appropriate processing documentation.
2. Ensures production schedule is followed and maintains critical product flow through the facility by effectively coordinating daily tasks and personnel to meet production demands and prevent unplanned downtime. Tasks include but are not limited to placing and retrieving dose verification devices, loading / unloading product into processing rooms and/or vessels; may load product onto pallets; stages processed product in shipping storage area.
3. Maintains required Operator certification(s), knowledge and understanding associated with the processing modality for which they are certified.
4. Operates and assists with the maintenance of the processing equipment to ensure the integrity of the sterilization process. Executes minor repairs, and initiates maintenance work orders for other repairs.
5. Monitors processing operation, control systems and equipment functionality to ensure safety and Customer specifications are met. Responds to process and equipment alarm conditions while acting within operational and safety guidelines.
6. Understands the scheduling process and can make recommendations to scheduling adjustments as needed.
7. Collaborates with supervision to ensure completion and effectiveness of training requirements, performance objectives and goals.
8. Contributes to a team effort by performing in accordance with all STERIS policies, GMP, Lean principles and other directives; supports the directives and decisions of higher-level management and performs other duties as assigned.

Duties - cont'd

1. A minimum of two (2) years of warehousing / manufacturing environment or experience (preferred).
2. Must successfully pass company Operator training program and maintain certification.
3. Must be certified to operate manual and motorized material handling equipment, including, but not limited to, forklifts, pallet jacks, elevators, conveyors, etc. and processing vessels or irradiators.
4. Possess specific licenses as required by law, i.e., New Jersey Pesticide Applicator’s License and Boilers License.

In a numbered list, describe specific skills and/or business competencies:

1. Must successfully pass company Operator training program.
2. Must be certified to operate manual and motorized material handling equipment, including, but not limited to, forklifts, pallet jacks, elevators, conveyors, etc. and processing vessels or irradiators.
3. Must possess specific licenses as required by law, i.e., New Jersey Pesticide Applicator's License and Boilers License.
4. Ability to pass a Nuclear Regulatory Commission (NRC) required background check for specific locations.
5. Ability to effectively read, write and verbally communicate.
6. Ability to work independently under general guidelines and supervision.
7. Requires ability to navigate through defined computer screens.
8. Above average organizing and analyzing skills and Level 2 math skills (four basic arithmetic functions in all units of measurement, decimals ratios, rates, percentages) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
9. Able to adapt to changing duties and responsibilities.
10. Basic understanding of sterilization principles and need for extreme caution handling product.

Education Degree

Required Experience

Minimum work experience required in addition to education above: Two (2) years of relevant external experience, or internal experience as a Material Handler is required.