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 setting.

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

📌 Technician - I MN (Midnight) (Mississauga)
🏢 SUN PHARMA
📍 Mississauga