Aseptic Process Technician

Company Overview

Job Summary

Major Responsibilities

• Adhere to GMP and ISO 13485 quality systems.
• Perform cleanroom line clearance and manufacturing cleanup.
• Participate in equipment installation, operation, qualification, mixing, filling, and sterilization.
• Participate in process validation, problem solving, quality improvement, and process improvement projects.
• Perform formulation, milling, dialysis, degassing, filling, and sterilization according to master batch instructions.
• Perform calibration, corrective and preventive maintenance, and documentation.
• Write SOPs and manufacturing documentation.
• Manage inventory, ordering, stock control, order tracking, and labeling.
• Communicate with suppliers about material and machine concerns and troubleshoot when needed.
• Coordinate manufacturing setup projects with QC, QA, and R&D.

Minimum Qualifications

• A three-year college diploma in a scientific field is required.
• One year of experience in a GMP, GLP, or ISO-compliant environment is required.
• Relevant environments include manufacturing, QC, QA, R&D, or another technical function.
• Excellent written and oral communication skills are required.
• Experience working in a cleanroom environment is required.
• Teamwork, clear writing, organization, planning, and flexibility are required.

Preferred Qualifications

• IQ/OQ/PQ experience with manufacturing or laboratory equipment is preferred.
• Calibration system setup or equipment calibration experience is preferred.
• Inventory management system setup or management experience is preferred.
• SOP writing experience is preferred.
• A bachelor's degree and pharmaceutical manufacturing experience are preferred.

Working Conditions

• The role requires working in cleanroom and laboratory areas for up to 90 percent of the time.
• The position is based in Aurora and requires in-person work.

Schedule

• The shift runs from 2:00 PM to 10:00 PM, Monday through Friday.

Compensation

• Pay is $48,000 to $53,000 per year.

Benefits

• Benefits include dental care, extended health care, on-site parking, RRSP matching, and vision care.