Aseptic Production Operator II

Overview

At Niagara, we’re looking for an Aseptic Production Operator II to ensure the safe, efficient, and compliant operation of aseptic manufacturing processes and equipment. The role focuses on maintaining sterile conditions, guiding junior operators, and upholding cGMP standards in a dynamic production environment.

• Execute aseptic manufacturing processes in accordance with standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP).
• Prepare, set up, operate, and monitor aseptic blowing/filling, cleaning, and sterilization of aseptic block equipment.
• Apply knowledge of chemicals used in the aseptic block equipment and their critical interactions (GHS & SDS).
• Understand microbielogy concepts, pH, low‑acid and high‑acid products, and causes of sterility loss.
• Monitor all critical control points (CCPs) of the block equipment using a Human Machine Interface (HMI) to maintain final product sterility.
• Identify and address potential contamination risks, collaborating with Supervisor, Quality, and Maintenance teams to mitigate or eliminate them.
• Operate, monitor, and troubleshoot aseptic block equipment such as filling, blow‑molding machines, sterilizers, and filtration systems.
• Detect equipment malfunctions or out‑of‑tolerance machining and adjust machine controls accordingly.
• Be alert to alarms and act quickly to prevent unnecessary downtime.
• Perform routine maintenance (cleaning, inspecting, lubricating – CIL) on the aseptic block equipment under Maintenance Technician supervision.
• Follow Quality Control procedures for in‑process checks, sampling, and inspections to ensure product quality and compliance.
• Perform visual inspections, measurements, and other quality control tests to identify deviations or defects and take appropriate corrective actions.
• Test torque, top load, bottle section weights, and cleaning/sterilization chemical concentrations (including titrations).
• Accurately document all production activities—Production Logs, Machine Reports, Quality Reports, and Downtime Reports—using software such as Presage and Infinity.
• Adhere to cGMP guidelines, regulatory requirements, and Niagara’s Quality Systems.
• Maintain a safe working environment by following safety protocols such as Lock‑out/Tag‑out (LOTO), wearing PPE, housekeeping, and participating in safety training programs.
• Report any safety incidents, near misses, or hazards to the Supervisor.
• Comply with Niagara’s Cost Control, Yield, and Employee Safety policies; equipment handling guidelines; and Food Safety Plan for aseptic beverage production.
• Work across multiple production areas with minimal supervision and perform relief duties when required.
• Use computer systems such as Oracle/MES or current order management systems.
• Understand line flow, potential bottlenecks, and manufacturing processes to maximize throughput.
• Communicate issues clearly and concisely.
• Maintain regular and predictable attendance; work 12‑hour shifts (day or night) on a rotating 2‑2‑3 schedule.

• Minimum 2 years of experience in a similar manufacturing environment and position operating aseptic machines (combined work experience and education is acceptable).
• Preferred 6 years of experience in a similar field or position and 2 years managing people or projects.

• Lead Like an Owner – make safety the top priority, alert for safety issues, and prioritize tasks based on department goals.
• Respond promptly, honor commitments, and deliver customer‑centric solutions.
• Make continuous improvement recommendations, adapt to unexpected changes, and increase performance through efficiency.
• Seek technical knowledge development, understand inter‑departmental impact, and solve problems rather than blame.
• Communicate clearly and manage expectations throughout the organization.

• Required:
  
  Technical High School Diploma or GED.
• Preferred:
  Associate’s Degree in Microbiology, Chemistry, or Engineering.
• Required certifications:
  None.
• Preferred certifications:
  Yellow Belt, Aseptic Processing and Packaging, Better Process Control school.
• Foreign language:
  None required or preferred.

Regular full‑time team members receive a…