Manufacturing Technician (Upstream)

Duty 1: Perform Cell Culture/Fermentation

Importance Experience - Training
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Avg. Rating Little Some More
Task A: Establish working cell bank
Take master cell bank vial out of cryo-unit 1.0 33.3 33.3 33.3
Thaw vial 2.0 0.0 100.0 0.0
Add media to autoclaved spinner flask 2.0 0.0 100.0 0.0
Inoculate spinner flask with contents of vial 1.5 50.0 50.0 0.0
Put spinner flask in incubator 2.0 0.0 66.7 33.3
Scale-up culture to fermentor volume 1.5 33.3 66.7 0.0
Dispense into vials 2.0 0.0 100.0 0.0
Put vials into cryo-unit 2.0 0.0 66.7 33.3

Task B: Perform vial thaw

Take working cell bank vial out of cryo-unit 2.4 0.0 80.0 20.0
Thaw vial 1.6 14.3 85.7 0.0
Add media to autoclaved spinner flask 1.7 14.3 71.4 14.3
Inoculate spinner flask with contents of vial 1.6 14.3 71.4 14.3
Put spinner flask in incubator 2.1 0.0 71.4 28.6
Incubate spinner for desired length of time 1.9 0.0 71.4 28.6

Task C: Perform scale-up ops

Remove spinner from incubator 1.9 0.0 71.4 28.6
Add media to next larger size spinner flasks 1.6 14.3 85.7 0.0
Aliquot culture from initial spinner into larger spinner
1.7 14.3 85.7 0.0
flasks
Incubate larger spinners 1.7 0.0 85.7 14.3
Send used spinner to equipment prep for turnaround 2.4 0.0 71.4 28.6

Task D: Inoculate seed reactor

Add growth media to sterilized seed reactor 1.6 0.0 100.0 0.0
Connect spinner flask to seed reactor 1.7 14.3 85.7 0.0
Steam feed port of reactor 1.7 0.0 85.7 14.3
Once port has cooled, transfer contents of spinner into
1.7 14.3 85.7 0.0
seed reactor
Perform post-steaming of feed port 1.9 0.0 85.7 14.3
Send used spinner to equipment prep for turnaround 2.4 0.0 71.4 28.6

Task E: Inoculate perfusion reactor

Add media to sterilized perfusion reactor 2.0 0.0 100.0 0.0
Steam transfer line 2.2 0.0 80.0 20.0
Allow transfer line to cool 2.6 0.0 60.0 40.0
Check for positive pressure 2.4 0.0 80.0 20.0
Transfer contents of seed reactor to perfusion reactor 2.2 0.0 100.0 0.0
Perform post-steaming of transfer line 2.4 0.0 100.0 0.0

Task F: Inoculate production reactor

Add production media to sterilized production reactor 1.4 14.3 85.7 0.0
Steam transfer line 1.6 0.0 85.7 14.3
Allow transfer line to cool 1.9 0.0 71.4 28.6

Copyright © 2005 Education Development Center, Inc., and New Hampshire Community Technical College 1
 Check for positive pressure 1.7 0.0 85.7 14.3
Transfer contents of perfusion reactor to production
1.6 14.3 85.7 0.0
reactor
Perform post-steaming of transfer line 1.9 0.0 85.7 14.3

Task G: Perform media addition

Pressure test media filter assembly and transfer line feed 1.3 14.3 71.4 14.3
Sterilize filter assembly and transfer line feed port 1.4 0.0 85.7 14.3
Allow assembly and line to cool 1.9 0.0 71.4 28.6
Add desired media volume to reactor 1.6 0.0 100.0 0.0
Perform post-steaming 1.7 0.0 85.7 14.3
Disassemble filter assembly port 1.6 0.0 85.7 14.3

Task H: Monitor culture parameters

Sample reactor 1.4 0.0 85.7 14.3
Run culture tests to confirm process parameters 1.7 0.0 85.7 14.3
Visually inspect reactor culture 1.7 0.0 85.7 14.3
Check display and trends for proper process parameters 1.6 14.3 71.4 14.3
Adjust set points as necessary to optimize culture 1.9 14.3 85.7 0.0

Task I: Execute sampling

Prepare sample apparatus 1.9 0.0 71.4 28.6
Aseptically take sample using appropriate sampling device 1.6 0.0 71.4 28.6
Aliquot required samples 1.7 0.0 57.1 42.9
Label, store, and submit sample 2.0 0.0 57.1 42.9
Make LIMS entries as needed 2.2 0.0 66.7 33.3

Duty 2: Follow Safety Procedures

Importance Experience - Training
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Task A: Wear appropriate safety apparatus
Check MSDS or relevant procedure 2.3 0.0 71.4 28.6
Don appropriate attire 1.3 0.0 71.4 28.6
Follow safety procedures relevant to task 1.1 14.3 57.1 28.6

Task B: Maintain safe working environment

Assess condition of working area 1.7 28.6 42.9 28.6
Fill out work order for hazardous conditions if necessary 2.4 0.0 83.3 16.7
Ensure floors are dry 2.4 0.0 66.7 33.3
Reduce clutter in work area 2.4 0.0 83.3 16.7
Be familiar with location of nearest safety station 1.6 0.0 50.0 50.0

Task C: Communicate potential hazards

Notify supervisor of any near misses 1.4 0.0 66.7 33.3
Verbally communicate to coworkers and oncoming shift
1.3 0.0 66.7 33.3
the details of potential hazards
Notify EH&S of potential hazards or near misses 1.6 0.0 66.7 33.3

Task D: Keep safety training up to date

Check database for your status on a regular basis 2.7 0.0 66.7 33.3
Attend safety trainings and meetings as required 2.1 0.0 50.0 50.0
Complete paperwork for safety trainings 2.0 0.0 50.0 50.0

Copyright © 2005 Education Development Center, Inc., and New Hampshire Community Technical College 2
 Duty 3: Follow GMPs
Importance Experience - Training
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Task A: Maintain training records
Fill out required documentation as you become proficient 1.4 40.0 40.0 20.0
Sign paperwork to show that you have read and
1.4 20.0 60.0 20.0
understood SOP's
Submit paperwork to training department 1.9 16.7 33.3 50.0
Perform any required electronic training 2.2 25.0 25.0 50.0

Task B: Update procedures as required

Review most current revision to verify accuracy 2.3 16.7 66.7 16.7
Identify any necessary changes 2.1 33.3 66.7 0.0
Fill out change request and revise document 2.9 20.0 80.0 0.0
Submit request for approval 2.9 16.7 66.7 16.7
Sign new revision 2.7 16.7 66.7 16.7

Task C: Follow documentated procedures

Obtain correct procedure and revision for task 1.7 16.7 66.7 16.7
Perform task as written in procedure 1.1 42.9 42.9 14.3
Document in a timely manner as required 1.1 14.3 71.4 14.3
Ensure verifier is present and documents, when required 1.0 16.7 50.0 33.3

Task D: Fill out batch records in a timely manner

Fill out batch records in a timely manner 1.1 0.0 85.7 14.3
Document and perform tasks in order as specified in
1.4 14.3 71.4 14.3
batch record
Ensure verifier is present for tasks requiring a verifier 1.1 14.3 57.1 28.6

Task E: Perform tasks in an ethical manner

Don't backdate 1.1 28.6 57.1 14.3
Don't forge 1.0 28.6 57.1 14.3
Document data directly from source 1.1 14.3 71.4 14.3
Don't falsify data 1.0 28.6 57.1 14.3

Duty 4: Use PC Skills

Importance Experience - Training
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Task A: Enter data for process parameters
Obtain data from batch record 2.4 14.3 71.4 14.3
Enter data into correct database 2.5 16.7 66.7 16.7

Task B: Operate process automation

Follow Procedure 1.2 16.7 66.7 16.7
Select appropriate recipe 1.8 20.0 40.0 40.0
Download recipe 2.0 20.0 40.0 40.0
Enter any specific process parameters required 2.0 16.7 66.7 16.7
Ensure operation runs properly 1.8 16.7 66.7 16.7
Ensure manual configurations are correct 1.8 16.7 50.0 33.3
Acknowledge prompts as needed 2.2 16.7 50.0 33.3

Task C: Fill out work order request

Copyright © 2005 Education Development Center, Inc., and New Hampshire Community Technical College 3
 Obtain work order form 2.9 0.0 85.7 14.3
Fill out required information using appropriate database 2.9 0.0 85.7 14.3
Describe identified problem 2.6 0.0 85.7 14.3
Describe work needed to repair 2.7 0.0 85.7 14.3
Submit request 2.9 0.0 71.4 28.6

Task D: Create/Revise procedures

Obtain document template in Word 2.8 0.0 80.0 20.0
Type up required steps to perform procedure sequentially 2.6 0.0 85.7 14.3
Fill out document revision request form 2.7 0.0 71.4 28.6
Obtain appropriate signatures 2.8 0.0 71.4 28.6
Submit for approval 2.8 0.0 66.7 33.3

Duty 5: Perform Sterilization

Importance Experience - Training
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Task A: Sterilize vessels and transfer lines
Ensure pressure test has been performed 1.6 14.3 71.4 14.3
Manipulate valves to specified orientation 1.7 0.0 85.7 14.3
Drain glycol from vessel jacket, if applicable 2.0 0.0 83.3 16.7
Run automated recipe 2.0 0.0 83.3 16.7
Ensure all set-points are reached 1.7 0.0 85.7 14.3
Upon completion of sterilization phase, manipulate valves
1.7 0.0 85.7 14.3
during cool-down as specified
Document as required 1.6 0.0 85.7 14.3

Task B: Sterilize sample device/port

Attach sterile sampling device 1.7 0.0 85.7 14.3
Run Sterilization per SOP 1.6 0.0 85.7 14.3
Cool per SOP 1.7 0.0 71.4 28.6
Sample from device 1.6 0.0 85.7 14.3

Task C: Autoclave equipment (same procedure for

depyrogenation ovens)
Assemble equipment per procedure 2.2 0.0 66.7 33.3
Load equipment into chamber 2.0 0.0 80.0 20.0
Select appropriate cycle 2.0 0.0 60.0 40.0
Run cycle 2.2 0.0 60.0 40.0
Ensure process parameters are met 1.6 0.0 80.0 20.0
Close valves and unload equipment 2.0 0.0 80.0 20.0

Duty 6: Clean Equipment

Importance Experience - Training
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Task A: Clean CIP vessels, transfer lines and filter trains
Ensure that CIP skid is ready for operation 2.0 0.0 71.4 28.6
Obtain required equipment-cleaning solutions such as
2.0 0.0 71.4 28.6
hoses, pump, etc.
Set up equipment as required 2.0 0.0 71.4 28.6
Run cleaning operation per SOP 1.9 0.0 71.4 28.6
Disassemble equipment 2.0 0.0 71.4 28.6

Task B: Perform WFI flush of transfer lines

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 Set up appropriate valves, hoses, etc. 2.0 0.0 66.7 33.3
Open WFI supply per procedure 2.0 0.0 66.7 33.3
Complete manual manipulations per procedure 1.8 0.0 66.7 33.3
Disassemble 2.0 0.0 75.0 25.0

Task C: Clean COP equipment (or sonicator)

Prepare solution in COP tank 2.0 0.0 100.0 0.0
Place equipment into bath 2.3 0.0 66.7 33.3
Soak for specified time 2.3 0.0 66.7 33.3
Rinse with WFI 2.3 0.0 66.7 33.3

Task D: Wash glassware equipment

Prepare glasswasher 3.0 0.0 100.0 0.0
Load equipment into glasswasher 3.0 0.0 100.0 0.0
Run appropriate cycle 2.7 0.0 100.0 0.0
Remove equipment and allow to dry 3.0 0.0 66.7 33.3
Prepare or wrap equipment 3.0 0.0 66.7 33.3
Task E: Perform scheduled sanitizations of hoods
Prepare disinfectant 2.1 0.0 57.1 42.9
Wipe down equipment surfaces starting from cleanest to
2.1 0.0 57.1 42.9
dirtiest
Wipe down surfaces with water 2.1 0.0 57.1 42.9
Wipe down surfaces with IPA 2.1 0.0 57.1 42.9

Duty 7: Prepare Buffers and Medias

Importance Experience - Training
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Task A: Weigh components
Calibrate scale 2.5 0.0 100.0 0.0
Obtain raw material 2.8 0.0 75.0 25.0
Tare container 2.8 0.0 75.0 25.0
Place raw material in container to specified weight 2.8 0.0 75.0 25.0
Close container 3.0 0.0 75.0 25.0

Task B: Dispense components

Move materials to appropriate storage area 3.0 0.0 75.0 25.0
Perform inventory transaction for movement 2.7 0.0 100.0 0.0
Record on batch record 2.0 0.0 100.0 0.0
Place batch record with materials 2.3 0.0 100.0 0.0

Task C: Prepare batch

Ensure systems have been sterilized and prepared as
2.2 0.0 100.0 0.0
necessary
Obtain raw materials 2.6 0.0 60.0 40.0
Charge batch vessel with WFI 2.6 0.0 100.0 0.0
Add specified raw materials 2.6 0.0 100.0 0.0
Mix for specified time 2.6 0.0 100.0 0.0
Filter and transfer to storage vessel 2.6 0.0 100.0 0.0
Store at specified temperate and assign expiration date 2.4 0.0 100.0 0.0

Copyright © 2005 Education Development Center, Inc., and New Hampshire Community Technical College 5
 Duty 8: Perform Testing
Importance Experience - Training
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Task A: Test integrity of filters
Wet Filters 2.1 0.0 71.4 28.6
Set up and attach tester 2.1 0.0 85.7 14.3
Execute test 2.1 0.0 83.3 16.7
Check for passing results 2.1 0.0 85.7 14.3

Task B: Perform pressure test

Set-up equipment 2.0 0.0 100.0 0.0
Pressurize equipment to desired pressure 2.0 0.0 100.0 0.0
Check for leaks 1.7 0.0 100.0 0.0
Monitor pressure loss for specified time 1.9 0.0 100.0 0.0
Ensure that passing criteria are met 1.7 0.0 100.0 0.0
Release pressure 2.0 0.0 100.0 0.0

Task C: Use testing probes

Obtain probes 2.0 0.0 71.4 28.6
Prepare probes for use 2.0 0.0 100.0 0.0
Standardize probes per procedure 2.0 0.0 100.0 0.0

Task D: Perform in-process testing

Obtain sample 1.7 0.0 100.0 0.0
Aliquot sample as required 1.9 0.0 71.4 28.6
Run sample on applicable meters 2.0 0.0 100.0 0.0
Record results 2.0 0.0 85.7 14.3

Task E: Perform cell counting

Obtain sample and hemocytometer 1.7 0.0 28.6 71.4
Dilute sample in trypan blue 1.6 0.0 28.6 71.4
Vortex sample 2.0 14.3 71.4 14.3
Pipette sample onto hemacytometer 1.6 0.0 28.6 71.4
Count cells under microscope 1.6 0.0 28.6 71.4

Duty 9: Perform Recovery/Filtration

Importance Experience - Training
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Task A: Run TFF skid
Buffer flush-equilibration 1.5 0.0 100.0 0.0
Download appropriate recipe 1.8 0.0 100.0 0.0
Initiate operation per procedure 1.5 0.0 100.0 0.0
Monitor trans-membrane pressure 1.8 0.0 100.0 0.0
Sample as necessary 2.0 0.0 75.0 25.0

Task B: Perform depth filtration

Ensure filters have been steamed and are ready for
2.0 0.0 100.0 0.0
processing
Charge solution to filters 2.2 0.0 100.0 0.0
Bleed filters 2.2 0.0 100.0 0.0
Monitor filtration 2.0 0.0 100.0 0.0

Copyright © 2005 Education Development Center, Inc., and New Hampshire Community Technical College 6
 Task C: Perform centrifugation
Set up centrifuge 1.3 33.3 66.7 0.0
Get bowl up to speed 1.3 33.3 66.7 0.0
Start feeding product 1.3 33.3 66.7 0.0
Monitor centrifuge 1.3 33.3 66.7 0.0
Adjust dislodge 1.3 33.3 66.7 0.0

Task D: Run homogenizer

Set-up Homogenizer 2.0 0.0 50.0 50.0
Start feeding 2.0 0.0 50.0 50.0
Apply pressure to pistons 2.0 0.0 50.0 50.0
Run two to three feeds 2.0 0.0 50.0 50.0
Monitor operation 2.0 0.0 50.0 50.0

Duty 10: Maintain Communication

Importance Experience - Training
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Task A: Deliver shift change update
Compose shift change update 1.9 0.0 100.0 0.0
Pass update on to Supervisor 1.6 0.0 100.0 0.0
Pass update onto oncoming shift 1.9 16.7 83.3 0.0

Task B: Contact appropriate groups for specific needs

Determine needs 1.9 16.7 83.3 0.0
Contact appropriate groups for specific needs 1.9 16.7 83.3 0.0

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