SD/SEV Sterile Technician

Specific Job Requirements

This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:

Primary Responsibilities(s)

Equipment Wash/Responsibilities

• Operates lab equipment.
• 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.      

Crimp Room Responsibilities

• 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

Mix Room Responsibilities (Upon Completion of additional training and qualification)

• 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

Sterile Room Responsibilities (Upon Completion of additional training and qualification)

• All Sterile Technicians will be required to participate in and have a passing Media Fill Trial before allowed to produce
• 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

Additional Responsibilities (On Occasion)

Labeling/Inspection Responsibilities

• Responsible for inspecting 100% of vials produced for defects
• Reject defected vials
• Must be detail oriented
• Ability to read and understand SOPs
• Must be able to sit or stand long periods of time and lift approximately 50 lbs. on a routine basis
• Good eyesight is required

Physical Demand(s)

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Requires Type 2, Type 3, or Type 4 Garb for entry into departmental work areas
• Requires all technicians to perform Personnel Monitoring for every entrance into Clean Room.  
• Requires standing for long periods of time using proper Aseptic Technique. 
• Will use step ladder to perform some required tasks.
• Requires repeated lifting of 5 to 10 pounds. 
• Requires occasional lifting of 85 pounds with assistance.
• While performing the duties of this job, the employee is frequently required to sit and talk or hear.
• The employee is occasionally required to use hands to finger, handle, or feel.
• Specific vision abilities required by this job include close vision and ability to adjust focus. 

Computer Skill(s)

To perform this job successfully, an individual should have knowledge of Internet software, Spreadsheet software and Word Processing software.