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RB Aseptic Process Technician III - Berkeley, CA 

RB Aseptic Process Technician III - Berkeley, CA

Purpose

Performs routine processes related to formulation, filling, freeze-drying, Capping, and sterile processing for all new and licensed products. Performs non-routine analyses for support of Process Sciences, Validation, facility or utility maintenance, and other projects as directed by a supervisor or designate. Performs routine process sampling for lab and equipment maintenance and re-qualifications. Performs routine and non-routine cleaning of the facility.

YOUR TASKS AND RESPONSIBILITIES

Will be fully trained and qualified in one of the following production skills as reflected in the area-approved training matrix. Must be able to be qualified in Class A/B owning, including media fill qualification. In addition, the job duties include:

• Execute Aseptic operations;

• Execute bulking activities;

• Execute filling activities;

• Prepare lyophilizer for a fills and unloads;

• Execute capping activities;

• Clean and sterilize equipment;

• Train coworkers;

• Execute various in-process sampling;

• Clean facility;

FORMULATION:

1. Trained and qualified in the basic knowledge needed to perform all aspects of the pre-bulking operation;

2. Trained and qualified in the basic knowledge needed to perform all aspects of the sterile filtration and final bulking operation;

3. Trained and qualified in the basic knowledge needed to perform all aspects of the formulation buffer preparation;

4. Trained and qualified in the basic knowledge needed to prepare and operate all equipment needed in the pre-bulking, sterile filtration, and final bulking operations;

5. Monitor and maintain housekeeping in work areas in accordance with cGMP;

6. Completes Documentation (BPR, SOP) training for the above-mentioned tasks and as identified in the approved training matrix;

7. Perform other duties as assigned.

FILLING:

1. Trained and qualified in the basic knowledge needed to operate one of the fill line stations (filler, stopper setter, trayer;

etc.). This will be qualified through a media fill;

2. Trained and qualified in the concepts of aseptic production, including gowning Class A-F;

3. Trained and qualified to perform the unloading operation and demonstrate capabilities of performing the unload as a member of an unload tea;.

4. Trained and qualified to enter Class A/B during a product fill;

5. Monitor and maintain housekeeping in work areas in accordance with cGMP;

6. Completes Documentation (BPR, SOP) training for the above-mentioned tasks and as identified in the approved training matrix;

7. Perform other duties as assigned.

STERILE PROCESSING:

1. Trained and qualified to operate at least two or more of the following pieces of equipment: Tunnel sterilizer, stopper washer, steam autoclaves, rinser, staging area, stopper drying ovens, and others as equipment changes may be performed;

2. Obtain supplies for the areas (both chemicals and components) and provide continuous inventory to match scheduled processing activities;

3. Trained and qualified to prepare cleaning solutions and materials. Sterile filtration of such solutions may be required;

4. Trained and qualified to assist in the unloading operation and demonstrate capabilities of performing the unload as a member of an unload team;

5. Monitor and maintain housekeeping in work areas in accordance with cGMP;

6. Perform other duties as assigned;

7. Completes documentation training (BPR, SOP) for the above-mentioned tasks and as identified in the approved training matrix.

STERILE PROCESSING OPERATIONS:

1. Trained and qualified to perform Class D cleaning;

2. Trained and qualified to perform Class A/B cleaning;

3. Trained and qualified to perform Freeze-Dryer cleaning in partnership with another area partner or with direct supervision;

4. Trained and qualified to prepare cleaning solutions and materials including Sterile filtration of such solutions as needed;

5. Trained and qualified to operate the steam autoclaves. Other equipment may be required as equipment changes may be performed;

6. Monitor and maintain housekeeping in work areas in accordance with cGMP;

7. Perform other duties as assigned.

FREEZE-DRYING OPERATIONS

1. Trained and qualified in the operations of freeze-dryers;

2. Trained and qualified in the freeze-drying process and how it relates to Bayer product in Berkeley;

3. Trained and qualified in the unloading operation of the freeze-dryers;

4. Trained and qualified in the cleaning, sterilizing and inspecting freeze-dryers;

5. Trained and qualified in sterilizing, integrity testing, and installing vent filters;

6. Trained and qualified in the monitoring and/or changing lubricants and perform fluid checks as they apply to the freeze dryers;

7. Trained and qualified to monitor the DCS;

8. Trained and qualified to operate at least two or more pieces of equipment: Tunnel sterilizer start-up, steam autoclaves, and others as needed;

9. Perform other duties as assigned

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Requires a high school diploma or GED; college courses in Chemistry, Biological Sciences, Microbiology preferable or an equivalent combination of education and experience;
• Aseptic technique and attention to detail is essential;
• Immunizations may be required;
• Must be able to qualify for plant aseptic owning requirements for Class 100-production area (Class A);
• The operator must be able to remove makeup, rings, watches, and all other jewelry as required for entry in specific cleanliness classification. Good hygiene must be adhered to;
• Must be able to work on one’s feet most of the day, have good visual acuity and color perceptions, and have good manual dexterity;
• Must be able to lift up to 75 lbs. and must be able to push/pull up to 180 lbs with assistance;
• Must be able to gown and work in a variety of clean room environments for long periods of time;
• Must be able to climb a stepladder;
• Must not have unusual sensitivity to typical laboratory chemicals (i.e., sanitization agents).

PREFERRED QUALIFICATIONS

• Prior aseptic gowning and processing techniques;
• Familiarity with a pharmaceutical, clinical or quality working environment.

Employees can expect to be paid a Union Wage of $39.76 per hour.  Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. 

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 4-30-25.

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