Job purpose
Cleaning & sanitizing packaging and compounding equipment and GMP working areas according to applicable SOP’s. May also be required to conduct duties of a Technician II, by operating filling and packaging equipment in a safe manner while maintaining compliance with cGMP and SOP requirements. Will be required to perform changeover and basic troubleshooting of Banding and Case Packaging equipment.
Duties and responsibilities
- Wash and sanitize miscellaneous and product contact parts for filling and compounding equipment.
- Clean and sanitize GMP areas according to applicable SOPs.
- Maintain miscellaneous and sanitization supplies.
- Complete all applicable GMP documentation such as cleaning & sanitizing records and logs.
- Assist with staging of components, raw materials and equipment parts.
- Assist custodial staff with cleaning of the premises (if required).
- Perform equipment set up as assigned.
- Complete all GMP Documentation related to batch documentation, correctly and in a timely manner.
- Complete all training assignments and maintain personal training records.
- Participate in Non-Conformance Investigations.
- Participate in Corrective and Preventive Actions (CAPA’s) investigations.
- Participate in Internal, Customer and Regulatory Audits.
- Work with safety in mind with respect to all assigned tasks.
- Supply Packaging lines with components for packaging.
- Monitor and adjust fill weights throughout the operation ensuring minimal overfill.
- Perform line changeovers, set up and troubleshooting, as assigned.
- Prepare detergent and sanitizing agents with the correct dilution factor.
- Sanitize filling rooms as per standard operating procedure.
- Participate in Line Clearance Processes both inside filling rooms and in packaging.
- Operate filling units and cartoners as required.
- Troubleshoot rapidly and effectively to ensure minimal line downtime.
- Assist with training of new hires.
- Ensure all established procedures followed to prevent contamination of the filling room, bulk products and equipment.
- Support line leader to ensure smooth operation and execution of Packaging Work Order (PWO).
- Assist Line Mechanics as required.
- Other duties as assigned
Additional responsibility (Only applicable to customer facing roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
- Minimum Grade 12 education or equivalent is required
- Experience in a pharmaceutical or related industry is preferred
- Mechanical aptitude. Experience with general tools and packaging equipment including labelling, printers and manual material handling equipment is preferred.
- Candidates are required to be able to add subtract, divide multiple, calculate average and percentages.
- Ability to effectively communicate in English (verbal, reading and writing), in order to communicate effectively with operations personnel is required.
- Excellent interpersonal skills.
- Ability to use a computer including Microsoft, SAP and Manufacturing Execution Software (MES) is preferred.
- A working knowledge and understanding of SOP’s required to be in compliance with cGMP’s is preferred
- WHMIS training is preferred.
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 20 lbs is required
- Operate lifting devices such as drum lifters, pallet trucks (manual and motorized) and pallet wrappers is preferred
- 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 walking throughout the day.
Direct reports
NA
