Technician - I (AM)

RiseMe; Brampton; On-site; CAD 42,000 - 52,000; Full time

Job summary

RiseMe in Brampton, Canada is seeking a Hygiene and Sanitation Technician to clean and sanitize packaging and compounding equipment and GMP work areas according to SOPs. You may also perform duties of a Technician II, operating filling and packaging equipment safely while maintaining cGMP compliance.

This role requires familiarity with GMP documentation, line changeovers, and assisting with training new staff; overtime and rotational shifts are possible; WHMIS knowledge is preferred.

Qualifications

• Minimum Grade 12 education or equivalent is required.
• Experience in a pharmaceutical or related industry is preferred.
• Mechanical aptitude with general tools and packaging equipment experience is preferred.
• Ability to communicate effectively in English (verbal, reading and writing).
• WHMIS training is preferred.

Responsibilities

• Wash and sanitize packaging equipment parts and surfaces.
• Clean and sanitize GMP areas according to SOPs.
• Maintain sanitization supplies and complete GMP records.
• Assist with staging components, raw materials and parts.
• Assist custodial staff with cleaning as required.
• Set up equipment and perform line changeovers as assigned.
• Complete GMP documentation for batch records and cleaning logs.
• Train new hires and maintain training records.
• Participate in Internal, Customer and Regulatory Audits.
• Ensure safety in all tasks and support Packaging Work Orders.

Skills

Mechanical aptitude

English communication

Interpersonal skills

Attention to detail

Education

Grade 12 education

Tools

SAP

Manufacturing Execution Software (MES)

Microsoft Office

Job description

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