TN01
JOB TITLE:Manufacturing Operator
DURATION: 6MONTHS CONTRACT
LOCATION:1025 Boulevard Marcel Laurin, Saint-Laurent ,Quebec, CAN-H4R 1J6
Job Summary
In compliance with established policies, guidelines, procedures, manufacturing instructions, Good Manufacturing Practices (GMP), health, safety and environmental requirements, and the business processes of the Montreal Site, the main responsibilities of the Manufacturing Operator are:
As a member of the process-centered team, the Manufacturing Operator is responsible for producing various dosage forms and performing different manufacturing steps such as weighing, granulation, blending, compression, encapsulation, coating, and inspection of solid, semi-solid, or liquid dosage forms, according to their area of specialization, while meeting requirements related to Safety, Quality, Delivery, Cost, and People.
The Manufacturing Operator is also responsible for cleaning and maintaining equipment, accessories, and the work area.
The operator performs production activities under their responsibility, carries out required inspections and controls, and accurately documents activities according to manufacturing records and standard work instructions.
Major ResponsibilitiesLevel 1
(Level 1 operators may perform a combination of the following tasks)
- Clean equipment parts, containers, production rooms, and work areas.
- Disassemble, clean, and reassemble production equipment according to procedures and GMP requirements.
- Plan cleaning activities to optimize production schedules and cleaning room utilization.
- Inspect equipment and parts for cleanliness and overall condition.
- Set up and start selected production equipment.
- Perform area clearance activities.
- Evaluate equipment and product quality.
- Complete and verify production documentation, including batch records, logs, cleaning labels, and standard work charts.
- Print and/or inspect tablets and capsules according to standards.
- Perform preventive maintenance activities (TPM).
- Polish punches and tooling.
- Manage waste, including pharmaceutical waste.
- Store production parts and components.
- Follow up on requests with specialists and supervisors.
- Handle equipment and materials such as powders, tablet cores, and tablets.
- Verify raw materials.
- Perform sanitation tasks.
- Conduct certain reconciliation activities.
- Maintain adequate inventory levels of supplies, materials, and products.
- Occasionally replace Level 2 Operators.
- Identify issues and suggest solutions.
- Participate in T0 and T1 meetings and continuous improvement activities.
- Train colleagues.
- Actively participate in continuous improvement programs and submit improvement ideas.
- Participate in team committees as required.
- Support training administration activities, including curriculum updates and procedure revisions.
Level 2
(Level 2 operators may occasionally perform Level 1 duties)
- Perform weighing, granulation, blending, compression, coating, ointment, cream, and liquid manufacturing according to batch records.
- Follow manufacturing instructions and process parameters and document activities.
- Perform in-process quality controls.
- Verify, calibrate, and maintain instruments and equipment.
- Calculate and perform adjustments such as pH and volume corrections.
- Enter transactions in computerized systems such as SAP.
- Manage and appropriately use tare weights.
- Monitor and document process parameters and product quality.
- Complete and verify GMP documentation.
- Handle powders, tablet cores, tablets, capsules, liquids, and semi-liquids.
- Clean and set up production equipment.
- Perform reconciliations.
- Optimize manufacturing parameters within approved limits.
- Monitor production activities.
- Prepare bulk product for packaging.
- Properly segregate and identify toxic containers and pharmaceutical waste.
- Palletize raw materials.
- Conduct physical inventory counts of raw materials.
- Dispense and de-dispense raw materials.
- Load and unload equipment.
- Plan daily work activities.
- Train colleagues.
- Participate in T0 and T1 meetings and continuous improvement activities.
- Follow standard work instructions.
- Participate in continuous improvement initiatives and idea-generation programs.
- Participate in team committees when required.
- Support training record maintenance and procedure updates.
Level 3
(Level 3 operators may occasionally perform Level 1 and Level 2 duties)
- Drive performance improvement and standard work initiatives using continuous improvement tools and methodologies.
- Act as a team leader and promote value-added activities.
- Coach and motivate the process-centered team to achieve shift production goals.
- Serve as a facilitator and subject matter resource.
- Support team members to meet operational objectives.
- Coordinate work organization and resource allocation.
- Anticipate problems and assist in issue resolution.
- Work closely with supervisors.
- Ensure GMP-compliant documentation and documentation review.
- Communicate expectations to team members.
- Conduct short-interval controls and monitoring.
- Participate in T0 and T1 meetings and continuous improvement activities.
- Ensure critical information is communicated to the next shift.
- Encourage team members to submit improvement ideas and promote the T-card system.
- Train and mentor colleagues.
- Actively participate in continuous improvement programs.
- Participate in team committees and special projects as required.
- Support training administration and competency development activities.
Education, Certification & Experience RequirementsRequired
- High School Diploma or equivalent.
Preferred
- Knowledge of Good Manufacturing Practices (GMP).
- Minimum 2 years of experience in the pharmaceutical industry or a related manufacturing environment.
- Mechanical aptitude.
- Basic computer skills.
- Experience with manufacturing equipment and production processes.
Pay: $27.00-$28.96 per hour
Language:
- French (required)
- English (required)
Work Location: In person
