SD/SEV STERILE TECHNICIAN

SD/SEV STERILE TECHNICIAN

Job brief
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.

Requirements
General Requirements

This position will require the employee to fulfill the following general requirements for employment at Stallergenes Greer Labs 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. 
 

Work Experience Requirements

One to two years work experience and/or training: or equivalent combination of education and experience.    
About STALLERGENES GREER International AG
Stallergenes Greer is an international biopharmaceutical company specialized in the diagnosis and treatment of allergies through the development and marketing of Allergenic Immunotherapy treatments.

Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.

Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.

With nearly 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 41 countries.

Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment ? Join our Stallergenes Greer teams !