Description
Job Title: Process Operator I
Location: Markham / ON / Canada
Duration: 06 Months (Temp to perm depending on performance)
Pay Range: $(21.00 – 22.78)/hr on T4
Shift Schedule: Monday – Friday 10:00 PM – 6:15 AM, 38.75 Hours a week – Two 30 minute breaks (1 paid, 1 unpaid)
Training Schedule: Training will be up to two months then transitioning to the night shift. The training will either be Monday – Friday 6:00 AM – 2:15 PM or Monday – Friday 2:00 PM to 10:15 PM. More details to be shared around the offer/clearance of screenings.
Position Summary:
- Provide an overview of the role, including job scope, responsibilities, impact, decision authority, problem solving, level of influence, etc.
- Manufactures products by operating various equipment in accordance with the Master Batch Record (MBR) and in compliance with EH&S policies, GMPs, and controlled procedures (SOP, EM, WI, JA, etc.) and performing troubleshooting and setup in a basic capacity, as required per Department/Site
Essential Duties & Responsibilities:
- Performs duties in accordance with the MBR and in compliance with EH&S policies, GMPs, and controlled procedures
- Completes all GMP documentation (MBR, controlled procedures, labels, logbooks, validation documentation, etc.) in accordance with Data Integrity
- Independently runs at least one (1) process type and performs all required in process checks (IPCs). Performs ERP data entry and transactions, and verification checks as required
- Conducts basic troubleshooting: Identifies issues and reacts to resolve (i.e. reset and fine tune equipment)
- Conducts basic equipment setup: Programming batch information, setup and configuration of equipment including dismantling, cleaning, and assembly of processing equipment/rooms according to controlled procedures
- Notifies Supervisor when processing issues, product quality concerns and safety incidents occur
- Ensures the proper care, use and condition of tools, equipment, rooms, and GMP area
- Retrieve, move and store materials in appropriate areas of facility, as required per Department/Site
- Supports and engages in OPEX activities/ initiatives (OEE, SMED, RCPS, Kaizen, 5S, etc.)
- Acts as a coach and supports training of new employees
Position Requirements:
Education:
- Identify the minimum education that would typically be required/preferred to perform this position
- Requirements should include course of study, degree level and major/field of study
- Required: Minimum successful completion of High school diploma or equivalent
- Preferred: Pharmaceutical Diploma or a university degree in a related science field
Experience:
- Identify the minimum years of experience that would be required/preferred for a candidate to enter this position
- Include the type of experience, ay specialty skill experience and/or supervisory/managerial experience required/preferred
- Required: 1 year experience in manufacturing environment
- Preferred: 1 year of experience in Pharmaceutical manufacturing
- Specialized Skills or Technical Knowledge Licenses, Certifications Required:
- Working knowledge of Windows applications, ERP systems, licensed on manual/motorized lift trucks, as required
Functional Knowledge:
- Demonstrated knowledge of GMPs, EH&S procedures, including OH&S Act, WHMIS
- Company / Industry Related Knowledge:
- General knowledge of Pharmaceutical or comparable GMP industry
- Job-Specific Competencies:
- Strong writing skills: Prepare written materials that are accurate, clear, logical and well organized
- Planning/Organizational skills: Organize and manage time to complete tasks and projects. Ability to multi task
- Problem solving: Ability to identify alternatives and solve routine problems, explain the processes to others (training)
- Math skills: Demonstrated ability to perform required computations, calculations and problems
- Interpersonal skills: Good interpersonal skills with the ability to work as part of a high performance team
Physical Requirements:
Sitting, standing, walking, ascending/descending stairs, heavy lifting (as per PDA), repetitive hand/finger work, wearing a respirator, PPE, harness, as required by tasks