Process Operator

Job Description:

• 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 concerns regarding product quality.
• 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).
• Perform other duties as assigned.

Experience and Qualifications:

• 1+ year of experience in a GMP manufacturing environment (pharmaceutical preferred).
• High School diploma or equivalent.
• Ability to wear required Personal Protective Equipment.
• Mechanical aptitude with high-speed machinery.
• Basic knowledge of Windows applications, SAP, and MSCA.
• Understanding of GMP standards and Health & Safety procedures (OH&S Act, WHMIS).
• Strong interpersonal and teamwork skills.
• Solid math and writing skills (online assessment required for interview consideration).
• Ability to multitask, plan, and solve routine problems independently.