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
- Technical responsibilities
- Perform mechanical setup, calibration, and adjustment of automated filling systems during product changeovers.
- Replace and maintained mechanical components including O-rings, valves, pumps, and nozzle assemblies to ensure proper equipment functionality.
- Conduct detailed mechanical trouble shooting as it pertains to container closure, folding station, and tube holders etc.
- 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.
- 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.
- Configure and adjust process parameters through HMI interfaces for automated filling and packaging systems, including program selection, recipe management, and format changeovers to ensure accurate machine operation and product quality.
- Troubleshoot, diagnose, and repair mechanical issues in packaging and filling equipment using appropriate tools and diagnostic techniques.
- Install, align, adjust, and replace mechanical components such as pumps, valves, pistons conveyors, and dosing systems.
- Dismantle, inspect, overhaul, and reassemble machinery and equipment to maintain operational efficiency.
- Collaborate with maintenance team members to resolve complex mechanical and operational problems.
- Conduct routine inspections and mechanical assessments to identify wear, defects, and potential failures.
- Calibrate and adjust equipment settings to ensure accuracy, safety, and product quality standards.
- Support continuous improvement initiatives by identifying mechanical inefficiencies and recommending corrective actions.
- Sign off required line start-up documentation in the primary and secondary areas prior to production run.
- Assist with training of new hires.
- Administrative responsibilities.
- 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.
- 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.
- Work with safety in mind with respect to all assigned tasks.
- Other duties as assigned.
Qualifications
- Minimum of a high school diploma or equivalent is required.
- Minimum of two years’ experience in a manufacturing/packaging environment is required.
- Experience in pharmaceutical industry is preferred.
- Experience with general tools and equipment including filling, cartooning, pumps and motorized material handling equipment is preferred.
- Experience with packaging changeover and set-up is required.
- Able to resolve minor and advance difficulties such as starting and stopping fillers, clearing “jam–ups” is required
- Candidates are required to 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 is required.
- Excellent interpersonal skills.
- Ability to use a computer including Microsoft, SAP and Manufacturing Execution Software (MES) is preferred
- Knowledge and understanding of cGMP’s compliance is required
- Forklift certification is preferred.
- WHMIS training preferred.
- Mechanical aptitude is a must
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