Sterile Manufacturing Technician

Stallergenes Greer; United States, Northern America, Americas; Sur place; USD 45 000 - 65 000; Plein temps

Résumé du poste

Stallergenes Greer Labs in Kentucky is seeking a manufacturing technician responsible for glassware preparation, sterile processing, and equipment readiness across multiple rooms. The role requires strict adherence to SOPs, quality checks, and precise documentation.

Training path includes Mix Room and Sterile Room duties as skills are gained. Responsibilities span wash/dep yro, crimp, and sterile operations, with occasional duties in labeling, inspection, and material handling.

Qualifications

• Must be detail oriented and able to follow SOPs.
• Ability to sit or stand for long periods and lift up to 50 lbs.
• Good eyesight and manual dexterity.

Responsabilités

• Washes, rinses, dries, inspects, and wraps glassware, vials, and equipment.
• Sterilizes or depyrogenates vials, glassware, and equipment.
• Maintains inventory of materials needed to complete production.
• Accurately documents work performed on documentation records or appropriate forms.
• Pull seals per Work Order for days production
• Breakdown of equipment
• Clean room and equipment pre- and post-production
• Return any unused seals to warehouse
• Responsible for pulling Sterility and LAL samples for QA
• Use balances to measure bulk chemicals by specifications on Batch Record
• Follow Documentation and SOPs to produce Sterile Diluents for production
• Transfer Sterile Diluent to Clean Room
• Perform Integrity testing on filters post-production
• Follow Documentation and SOPs to clean equipment pre- and post-production
• All Sterile Technicians will be required to participate in and have a passing Media Fill Trial
• Unload DHO and Autoclave daily
• Operate Equipment according to SOP
• Perform volume checks as required
• Produce Diluent/Sterile Empty Vials and operate Stoppering Mechanism
• Break down and sanitize equipment and change parts post-production
• Setup fill line for next day's production
• Labeling/Inspection of 100% of vials for defects
• Must be detail oriented
• Must be able to read and understand SOPs
• Must be able to sit or stand long periods and lift 50 lbs routinely
• Good eyesight

Connaissances

Detail oriented

Reading SOPs

Aseptic technique

Attention to safety

Formation

High School Diploma or equivalent

Outils

MS Office

Description du poste

Stallergenes Greer Labs in Kentucky is seeking a manufacturing technician responsible for glassware preparation, sterile processing, and equipment readiness across multiple rooms. The role requires strict adherence to SOPs, quality checks, and precise documentation.

Training path includes Mix Room and Sterile Room duties as skills are gained. Responsibilities span wash/dep yro, crimp, and sterile operations, with occasional duties in labeling, inspection, and material handling.