The opportunity
Process Operator, Compounding - 12 month contract (Night Shift, Training on Days)
The Process Operator manufactures products by operating various equipment's 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 an intermediate capacity, as required per department / site.
How you’ll spend your day
- Performs duties in accordance with the master batch record (MBR) and in compliance with EH&S policies, GMPs, and controlled procedures (SOP, EM, WI, JA, etc.)
- Completes all GMP documentation (MBR, controlled procedures, labels, logbooks, validation documentation, etc.) in accordance with Data Integrity, in their area of responsibility.
- Independently runs at least two (2) process types and performs all required in process checks (IPCs). Performs ERP data entry and transactions, and verification checks as required.
- Conducts intermediate troubleshooting : Optimizes all settings, parameters and adjustment of equipment within area of responsibility or process type.
- Conducts intermediate equipment setup : Independently fully disassembles and sets up equipment within area of responsibility or process type, includes dismantling, cleaning, and assembly of processing equipment / rooms according to controlled procedures within area of responsibility.
- 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.
- Retrieves, moves and stores materials in appropriate areas of facility, as required per Department / Site.
- Attends the Train the Trainer Program. Performs training on equipment, controlled procedures, and best practices as required per Department / Site and acts as a coach to Process Operators.
- Understands and acts on areas of productivity losses, looks for and suggests solutions, support OPEX initiatives (i.e. Kaizen, SMED, OEE, 5S)
- Performs other duties as assigned.
Your experience and qualifications
- 1+ year experience in GMP manufacturing environment. Preferred : 1+ year of relevant pharmaceutical experience.
- Minimum completion of High School required
- Ability to wear required Personal Protective Equipment
- Demonstrated mechanical ability with high-speed machinery
- Basic working knowledge of Windows applications, SAP, MSCA
- General knowledge of Pharmaceutical or comparable GMP industry
- Good knowledge of Health & Safety procedures, including, OH&S Act & WHMIS
- Good interpersonal skills with the ability to work as part of a high-performance team
- Strong writing skills : Prepare written materials that are accurate, clear, logical and well organized
- Math skills : Demonstrated ability to perform required computations, calculations and problems
- Planning / Organizational skills : Organize and manage time to complete tasks and projects. Ability to multitask
- Problem solving : Must demonstrate ability to identify alternatives and solve routine problems, e.g., ability to troubleshoot a process or equipment issue and explain the processes to others (training)
- Candidates shall be required to demonstrate mathematical and written skills by completing an on-line assessment to be considered for interview
7 days ago