Title:  Technician - II

Technician – II / Senior Technician

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.