Job Description

Job Title: Process Operator I
Location: Stouffville, Ontario, CAN, L4A1H5
Duration: 12 Months

Training Shift: 06:00 to 14:15
Night Shift hours: 22:00 to 06:15

Position Summary:
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

Job 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

Additional Requirements:

• Job requires hand - eye coordination, auditory, visual and tactile skills to perform job duties effectively
• Perform other related duties as required

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