Sr. Manufacturing Technician, SD/SEV Aseptic

General Requirements 
This position will require the employee to fulfill the following general requirements for employment at 
Stallergenes Greer and includes but not limited to: 
 Practice good hygiene and personal sanitation practices 
 Compliance with applicable standard operating procedures 
 Compliance with company environmental health and safety procedures 
 Protect and preserve Stallergenes Greer physical property and equipment 
 Protect and preserve Stallergenes Greer intellectual property and confidential information 

Education Requirements 
This position requires the following minimum education: 
 High School Diploma or equivalent. 
 Associate’s degree/Certification in Biology/Pharma related discipline preferred 

Work Experience Requirements 
 5+ year’s work experience in manufacturing 
 2+ years experiences training/leading others 
 Experience working with a medium/high speed fill line 
 Isolator/Rabs experience a plus 
Ability to write/modify GMP documents & write/review deviations

Specific Job Requirements 
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: 
o Coordinates scheduling of routine activities and assigns tasks to personnel. Coordinates 
activities of personnel to effectively meet production timelines. 
o Checks inventory and orders supplies as necessary based on schedule. 
o Assists with investigations of deviations. 
o 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. 

Personnel Job Description 
 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 

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 4 Garb qualification (Sterile Containment Suit, Sterile Hood, Sterile Face Mask, 
Sterile Gloves, Sterile Boots, and Sterile Goggles). 
 Must be able to perform Personnel Monitoring for every entrance into Clean Room. 
 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.