Sr. Manufacturing Technician, SD/SEV Aseptic

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

Job Task(s)

• Partially responsible for training in all areas of the department as needed
• Assist Crew Leader with tasks as needed:
  • Coordinates scheduling of routine activities and assigns tasks to personnel. Coordinates activities of personnel to effectively meet production timelines.
  • Checks inventory and orders supplies as necessary based on schedule.

• • Assists with investigations of deviations.
  • Ensures batch documentation is being completed according to appropriate GMP standards.

• Has technical skills to troubleshoot problems as they arise and to identify potential issues. Communicates issues requiring maintenance to appropriate personnel.
• Communicates production status in a timely manner.
• Effectively communicates schedule or process changes to affected personnel in a timely manner.

Equipment Wash/Responsibilities

• Operates lab equipment.
• Washes, rinses, dries, inspects, and wraps glassware, vials, and equipment.
• Sterilizes or dehydrogenates 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