Title:  Technician - I MN (Midnight)

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