Technician - II

Job purpose

The Technician II, maintains component and bulk product supply to packaging lines, washes and assists with filler assembly, disassemble, set-ups and changeovers.  Operates filling lines and packaging equipment in a safe manner and maintains compliance with cGMP and SOP requirements. Will be required to perform set-up, changeover and troubleshooting of Primary and secondary packaging equipment such as, Fillers, Drum Transfer Pumps, Cartoner, Case Packer and Banders.

Duties and responsibilities

Training Level 1 to 2:
•    Operate filling lines and equipment.
•    Supply filling lines with components and bulk product 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 area.  
•    Complete G.M.P. documents right first time, for example cleaning & sanitization records, packaging batch records, 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, Carton Tracker based on established change parts and parameter values.
•    Assist mechanics in doing preventive and corrective maintenance tasks.
Qualifications

•    Minimum Grade 12 education or equivalent.
•    Minimum 2-3 years’ experience in a pharmaceutical or related industry.
•    Mechanical aptitude. Experience with general tools and equipment including filling, cartooning, pumps and motorized material handling equipment is an asset.
•    Able to resolve minor and advance difficulties such as starting and stopping fillers, clearing “jam–ups”.
•    Excellent math skills. Must be able to add subtract, divide multiple, calculate average and percentages.
•    Excellent command of the English language combined with strong written, comprehension and oral communication skills. 
•    Excellent interpersonal skills.
•    Ability to use a computer including Microsoft, SAP and Manufacturing Execution Software (MES).
•    A good working knowledge and understanding of SOP’s required to be in compliance with cGMP’s.
•    Forklift certification is an asset.
•    WHMIS training an asset.

Working conditions

•    Overtime will be required. This may be additional time during the work week and / or on weekends.
•    Unless pre-arranged the position is considered to be a “rotational shift“ based on 37.5 hours per week (bi-weekly rotational is only for continental shift). 
•    GMP garments required to be worn within the manufacturing environment.

Physical requirements

•    Ability to safely lift up to 60 lbs.
•    Operate lifting devices such as drum lifters, pallet trucks and pallet wrappers.
•    A significant time will be spent washing and sanitizing equipment resulting in exposure to water, cleaning agents and a high humidity environment.
•    Ability to able to stand for long periods of time.   Also, bend, squat and walk throughout the day.

Direct reports

NA