Title: Technician - II MN Shift
General Summary:
The Technician maintains component supply to packaging lines, washes and assists with filler assembly. Operates filling lines and packaging equipment in a safe manner and maintains compliance with cGMP and SOP requirements.
Principal Duties and Responsibilities:
Training Level 1 to 2:
- Operate filling lines and equipment
- Supply filling lines with components and bulk for packaging
- Ensure drum and lot changes are completed effectively and on-time with minimal bulk waste
- Set-up, monitor and adjust fill weights throughout the operation ensuring minimal overfill
- Assemble and disassemble equipment such as fillers, manifolds, tube holders and supply pumps
- Perform filler changeovers, set-ups and troubleshooting
- Prepare detergent and sanitizing agents with the correct dilution factor
- Sanitize filling rooms as per standard operating procedure
- Perform housekeeping tasks such as washing floors, walls etc.
- Perform line clearance processes both inside filling rooms and secondary packaging
- Complete G.M.P. documents right first time, for example cleaning & sanitization records, packaging work orders, non-stationary equipment logs etc.
- Wash and sanitize wetted change parts for fillers and supply pumps
- Troubleshoot machine problems effectively based on the observed abnormalities
- Change embossing/coding block characters (expiration date and batch number) for metal and laminate tubes as specified on the packaging work order (PWO)
- Set-up/change-over of product contact parts (hopper, graco pump, directional valve, auger, dosing pump, nozzle etc.)
- Sign off required line start-up documentation in the primary and secondary areas prior to production run
- Assist with training of new hires
- Assist Line Mechanics, as required
- Work with safety in mind with respect to all assigned tasks
- Other duties as assigned.
Training Level 3:
- Set-up/change-over filling (primary) equipment as required
- Replace o-rings for directional valve, dosing pump, nozzle assembly etc.
- Perform more detailed trouble shooting as it pertains to container closure, folding station, and tube holders etc
Training level 4:
- Change embossing/coding block characters (expiration date and batch number) for labels and cartons as specified on the packaging work order (PWO)
- Changeover and set-up (and change parts as required) of secondary packaging equipment – cartoner, labeler, pester/bundler and case packer based on established change parts and parameter values
- Assist mechanics in doing preventive and corrective maintenance tasks
Knowledge, Skills and Abilities:
- Demonstrated mechanical aptitude combined with experience with mechanical set-ups on packing and filling lines in a pharmaceutical, food or similar GMP manufacturing environment.
- Excellent math skills.
- Excellent command of the English language combined with strong written and oral communication skills.
- Excellent interpersonal skills with ability to work effectively in a team-based environment.
- Ability to use a computer including Microsoft and Manufacturing Execution software.
- Fork lift certification an asset
Background and Experience:
- Minimum Grade 12 education or equivalent.
- Minimum two (2) years of experience in a pharmaceutical or related industry.
Problem Solving:
- Able to resolve minor difficulties such as starting and stopping fillers, clearing “ jam – ups “.
- Typically when a problem arises the line leader, line mechanic and or supervisor will be able to assist.
Working Conditions:
- Ability to able to stand for long periods of time.
- Ability to safely lift up to 60 lbs.
- Operate lifting devices such as drum lifters, pallet trucks and pallet wrappers.
- Overtime will be required. This may be additional time during the workweek and / or on weekends.