Production Tech 2 Job at ALK-Abello, Inc
NIGHT SHIFT POSITION SHIFT DIFFERENTIAL
A manufacturing technician may perform one or more of these job roles in support of the automated high-volume sterile fill production lines. The following is a list of specific duties, etc., which are considered to be essential functions of the job role. The lists are not all-inclusive and the employee who occupies the position is expected to assume any/all duties assigned by management, irrespective of whether such duties are specifically included in the list.
Capper: Perform all sealing/capping of vials associated with aseptic filling and manufacturing of sterile injectable solutions and sterile empty vials.
Assembly and part changeover of capping machine for capping operations
- Sealing/capping of sterile empty and/or sterile filled vials after they are processed on the filling/stoppering equipment
- Perform Environmental Monitoring (EM) throughout and at the end of capping
- Must pass a capping qualification test (media fill) in order to perform capping activities
- Must pass a sterile gowning qualification test in order to enter capping cleanrooms
Equipment Preparation Technician: Perform all equipment preparation associated with aseptic filling and manufacturing of sterile injectable solutions and sterile empty vials.
Washing/cleaning of product contact parts of filling and stoppering machine
- Preparing/wrapping product contact parts of the filling and stoppering machine
- Prepare appropriate quantity of stoppers required for daily production
- Load and operate steam sterilizing autoclaves
- Perform Environmental Monitoring (EM) when applicable throughout and at the end of washing
Filling Technician (semi-automated): Perform aseptic vial filling and manufacturing of all sterile injectable solutions and sterile empty vials.
Must pass a filling qualification test (media fill) in order to perform filling activities
- Must pass a sterile gowning qualification test in order to enter filling cleanrooms
- Remove sterilized vials from dry heat oven prior to processing when required
- Aseptically assemble automated filling equipment for sterile operations
- Aseptically process sterile empty vials and/or filling of sterile injectable drugs or diluting solutions
- Perform Environmental Monitoring (EM) throughout and at the end of filling
Formulation Technician: Perform all formulation activities associated with aseptic filling and manufacturing of sterile injectable solutions.
Washing/cleaning/inspection of product contact parts of formulation vessels and mixing equipment
- Formulating appropriate quantity of product required for daily production
- Perform Environmental Monitoring (EM) when applicable throughout and at the end of formulation
Packaging Technician: May be responsible for one or more of the job roles described below. All packaging technicians are expected to assist in areas other than their primary job when necessary.
Print tray or box labels and submit to Quality Assurance for approval before use
- Affix tray or box labels to trays/boxes
- Package vials into trays and/or boxes
- Perform in-process vial, tray, or box label checks
- Operate vial tray shrink-wrap machine
- Seal boxes of vials with packaging tape
- Stack trays or boxes of vials on carts or pallets
- Retrieve components needed for cleanroom operators
- Perform line clearances of labeling and packaging areas
- Move product from manufacturing areas to quarantine
Vial Inspector Technician: Perform vial inspection of sterile injectable solutions and sterile empty vials.
Must pass an annual eye exam by a certified optometrist
- Exams consist of visual acuity and color blindness
- Must pass a visual inspection test kit in order to qualify as a vial inspector
- Fully document and sign off on work performed
- Identify and remove defective material on a fast paced assembly line
- Correctly categorize defects and place them in appropriate reject bins
- Package vials in trays, cartons, or boxes
Vial Labeling Technician: Perform all labeling of vials associated with filling and manufacturing of sterile injectable solutions and sterile empty vials.
Assembly and part changeover of vial labeling machine
- Obtain appropriate labels and have a sample printed label checked by Quality Assurance
- Load trays of vials on labeling machine rotary table
- Operate the labeling machine according to operation SOPs
- Load table, change ink ribbon, labels when necessary
- Package vials into appropriate trays, cartons, or boxes
Vial Wash Technician: Perform all washing of vials associated with aseptic filling and manufacturing of sterile injectable solutions and sterile empty vials.
Assembly and part changeover of vial washing machine
- Continuous loading of vials for vial washing operations
- Perform Environmental Monitoring (EM) when applicable throughout and at the end of washing
Applicable to all manufacturing technicians working in clean rooms:
Sterile gowning that requires balance and attention to detail
- Plant dedicated scrubs and shoes must be worn at all times in cleanrooms
- No make-up, nail polish, and/or jewelry may be worn in cleanrooms
Applicable to all manufacturing technicians:
Strictly follow SOPs Standard Operating Procedures
- Follow cGMP, current Good Manufacturing Practices as outlined in 21 CFR Part 211
- Fully document and sign off on work performed
- Clean equipment post manufacturing activities
- Must wear lab coats and hair nets in manufacturing and labeling areas
Physical/Mental:
- Continuous mental and/or visual attention to manufacturing functions
- Continuous sitting throughout 3-4 hour period, or 2-3 hour period (Inspection Technician), or 6-8 hour period (Packaging Technician, Vial Labeling)
- Continuous light lifting of vials to eye level throughout a 2-3 hour period (Inspection Technician)
- Sterile gowning that requires balance and flexibility (Cleanroom Technicians)
- 95% of time spent in class 100 or 10K cleanroom, fully gowned including head covering, face mask, and goggles
- Lifting up to 50 lbs., or 30 lbs (Inspection Technician), frequent pulling, pushing and bending
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