Permanent

Senior Aseptic Operator

SalaryCompetitive
LocationUnited States
SectorPharmaceuticals & Biotechnology

Description

Job Description: Senior Aseptic Operator

Location: United States

Position Summary

The Sr. Aseptic Operator, IV Bag Manufacturing is responsible for overseeing a team of Operators for the performance of all necessary tasks within the classified areas for the manufacture of safe and effective sterile (injectable) IV bag pharmaceutical products in coordination with isolation technology. The Sr. Aseptic Operator is an extension of the Production Manager, a role model of quality, culture, and technique within the classified processing areas and the driver of day to day activities in alignment with key performance objectives. Understands how the department works in support of site objectives and goals as well as internal/external customer needs.

Key Responsibilities

  • Knowledge and understanding regulatory requirements such as 21CFR part 210 and 211, CGMP’s, FDA, OSHA and other regulatory agencies.
  • Ability to draft site SOP’s and CGMP’s relative to the positions within classified areas, and partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. 
  • Participate in and lead all aspects of manufacturing within the classified processing areas.
  • Set-up, operation, and troubleshooting of manufacturing equipment: including (but not limited to) filler, isolator, autoclave, parts washer, formulation skid, inspection/packaging equipment, etc.
  • Responsible for training and mentoring of new or less experienced Operators.
  • Assist in the development and execution of equipment and process qualification, validation, and protocols related to all aspects of IV Bag Filling using Isolator Technology
  • Perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) prior to the end of the shift.
  • Ensure that daily production is running efficiently, both in terms of output and quality.
  • Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
  • Monitoring and coaching personnel on executing processes and behaviors.
  • Responsible for scheduling of Operators to meet the needs of the department.
  • Reviews documentation generated by the Operators for completeness and facilitates necessary corrections and reinforcement training (as required).
  • Participate in investigations, and execute appropriate approved corrective / preventative actions for classified area related processes.
  • Ensure that the current requirements for Environmental, Health, Safety (EHS) issues are met within the production operations.
  • Include relevant stakeholders in decision-making in regards to equipment, processes and other daily operations.
  • Work methodically with an acute awareness of the direct and indirect impact of all actions performed.

Requirements

  • High School Diploma or GED preferred
  • 5-8 years of related work experience in a regulated environment preferred
  • Bachelor’s or Associate degree is preferred
  • Strong Leadership skills
  • Strong Mechanical abilities preferred
  • Willingness to work overtime (when required)
  • Experience with IV Bags Filling systems
  • Working Knowledge of Isolation Technology in a Pharmaceutical Environment
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