Title:  Technician - I (PM)

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
• Experience in a pharmaceutical or related industry is an asset.
• Mechanical aptitude. Experience with general tools and equipment including labelling, printers and manual material handling equipment is an asset.
• Excellent math skills, must be able to add subtract, divide multiple, calculate average and percentages.
• Good communication skills, written and verbal, in order to communicate effectively with operations personnel.
• Fluent in English (verbal, reading and writing 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.
• 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 20 lbs.
• Operate lifting devices such as drum lifters, pallet trucks (manual and motorized) 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 walking throughout the day.

Direct reports

NA