SD/SEV Sterile Technician

Stallergenes Greer; United States; On-site; USD 45,000 - 65,000; Full time

Job summary

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.

Responsibilities

• 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

Skills

Detail oriented

Reading SOPs

Aseptic technique

Attention to safety

Education

High School Diploma or equivalent

Tools

MS Office

Job description

Primary Responsibilities(s)

Equipment Wash/Responsibilities

• 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
• 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 !

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

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

The IT Application Manager’s overall responsibility is to oversee and streamline operations support for Stallergenes Greer Oracle JD Edwards installation, manage delivery efforts for new