Durham, NC 27709
Salary: $15.00 to $17.00 /hour
The Process Operator sets up, operates, documents, and monitors all assigned production processes using standard tools, equipment and operating specifications. The operator is directly responsible for the quality of the product produced and the accurate documentation of all assigned work. This role reports to the shift supervisor or manager and may work shift hours (1st, 2nd or 3rd shift) as required.
· Set-up and operation of the assigned process equipment according to written specifications and engineering instructions.
· Measurement of product using available metrology.
· Inspection of product as required.
· Judge acceptability of the product compared to documented standards.
· Routine Maintenance and cleaning of the process equipment and working area.
· Periodic equipment condition checklists and corrective action.
· Safe operation of assigned process equipment per specification.
· Review and completion of product documentation for correct processing parameters and operating conditions.
· Inventory and requisitioning of consumable items in the work area.
· Coordination of product movement between other manufacturing operations.
Key Responsibilities as % Of Job
· Process product in accordance with specifications including cartridge and reagents. Complete lot travelers and process paperwork/logs. 75%
· Perform and document routine maintenance on the equipment per specification. 5%
· Identify and document all equipment and process non-conformances. <5%
· Adhere to safe practices as established for the equipment and process. <5%
· Perform all tests, inspections, or measurements used in determining product conformance. 5%
· Maintain material inventories sufficient to support process requirements.<5%
· Perform data entry and basic mathematical calculations. 5%
· Provide operational support to process development and engineering as required.<5%
· Adhere to clean room protocol and procedures.<5%
· Coordinate movement of material between work areas and between shifts.<5%
· Other tasks as assigned. <5%
Knowledge / Skills / Abilities
· Experience in the operation of automated or complex manufacturing equipment in a high-volume, low-cost production operation.
· Ability to read and comprehend detailed technical specifications and accurately execute the prescribed operations with minimal supervision.
· Ability to recognize out-of-spec conditions on both equipment and process and to take appropriate corrective actions to ensure protection of the product and equipment.
· Ability to examine product using a microscope or other metrology equipment, measure critical product features and determine acceptability according to documented standards.
· Ability to perform routine maintenance on process equipment per specification.
· Ability to set up and maintain a clean and organized work station.
· Ability to perform repetitive operations for long periods of time, either sitting or standing.
· Ability to lift and manipulate 10-20 lb. objects routinely.
· Limited experience with formulation and liquid handling
· Experience working with quality systems
· Experience working with quality documentation including batch records, maintenance logs, NCRs, CAPAs, etc.
· Basic experience using Microsoft Excel
· Previous manufacturing experience in a high volume, cleanroom environment (Biotech, Microelectronics, or Electronics) is preferred
· Must have flexibility in working schedules and be able to work overtime with reasonable notice.
Education / Experience
- Associates Degree or Technical Training preferred
- 2-5 years direct high-volume manufacturing experience or an equivalent combination of education and experience