Process Operator I
Job Responsibilities:
- Manufacture products by operating equipment according to the Master Batch Record (MBR)
- Complete GMP documentation (MBRs, labels, logbooks, validation records) with accuracy and integrity
- Independently run at least two process types and perform all required in-process checks (IPCs)
- Conduct ERP data entry and verification checks
- Perform intermediate troubleshooting and optimize equipment settings
- Fully disassemble, clean, and reassemble equipment and rooms per controlled procedures
- Notify supervisors of any processing issues, safety incidents, or product quality concerns
- Maintain tools, equipment, and GMP areas in proper condition
- Retrieve, move, and store materials as needed
- Participate in the Train-the-Trainer program and coach other operators
- Support OPEX initiatives (Kaizen, SMED, OEE, 5S)
Skills:
- 1+ year of experience in a GMP manufacturing environment (pharmaceutical preferred)
- Ability to wear required Personal Protective Equipment
- Mechanical aptitude with high-speed machinery
- Basic knowledge of Windows applications, SAP, and MSCA
- Understanding GMP standards and Health & Safety procedures (OH&S Act, WHMIS)
Education/Experience:
- High School diploma or equivalent
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