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.