Engineering Aseptic Specialist

One of our key strengths at the AbbVie Biologics Ballytivnan site is our ability to deliver products to our patients manufactured in an aseptic environment and keeping a high level of focus in this area is key to our continued success as a site. To further enhance our skill set in this area, we are building an Aseptic Subject Matter Expert (SME) team and are now recruiting an Aseptic Manufacturing SME.

Your Purpose

As a member of the Aseptic Operations function, and as an Aseptic Manufacturing SME, ensures that Equipment for Aseptic Manufacturing (Equipment/ Cleanroom/ Utility) is designed according to AbbVie standards and Network Best Practice and is operating as designed.   Partners with Site colleagues and other members of the Site Aseptics team, to create an environment of the highest performance standards of Aseptic Manufacturing.  Drives continuous improvement in Aseptic Manufacturing Equipment on site.

Your Responsibilities (in addition to other duties as assigned)

• Acts as the Subject matter Expert for Equipment, Cleanroom and Utility systems related to Aseptic Manufacturing
• Responsible for ensuring that Equipment, Cleanroom and Utility systems required for Aseptic Manufacturing are in compliance with relevant Safety and Environmental Regulations, Aseptic and GMP Regulatory requirements and Network Aseptic Best Practice.
• Supports existing process Engineering systems related to Aseptic Manufacturing are operating as designed through:
  • Real-Time monitoring of Cleanroom performance (e.g., temperature, Relative Humidity, Differential Pressure, Air Fow velocity etc.)
  • Real-Time monitoring of Utility performance
  • Real-time monitoring of Critical Equipment cycles (e.g., CIP, SIP, VHP, Aseptic Filling, Autoclaves, Lyophilization, Depyrogenation, Bulk Heat Sterilization etc.)
  • Monitoring, investigation and addressing of Automation alarms
  • Trending performance and developing/ executing action plans as required
• Partners with other members of the Site Aseptics Team (e.g., Quality SMEs, Operations SMEs, Aseptic MQA and Aseptic mentors) to ensure required support is provided to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner, assuring sterility of the product. 
• Participates in troubleshooting & Investigation for equipment/ cleanroom/ Utility related events.
• Actively participates and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.
• As part of the Site Aseptics Team, drives continuous improvement of Aseptic Manufacturing Engineering systems and procedures through:

1. Continuously assessing, interpreting, and applying new Aseptic Manufacturing Regulations to Site Engineering systems in a timely manner.
2. Development and implementation of Best Practices in Aseptic Manufacturing.

• Ensures Equipment, Cleanroom, Utility Design related to Aseptic Manufacturing is in compliance with AbbVie standards and Network Best Practice though:
  • Provides key input into of the design of systems
  • Ensuring an extensive knowledge of the systems
  • Ensuring an extensive knowledge of AbbVie Engineering standards
  • Ensuring that any deviation from AbbVie Engineering standards goes through the required approval process.
  • Leading Projects related to equipment, cleanroom and utility equipment change.
  • Ensuring all alarms are ranked according to criticality.
• Approves Preventative Maintenance strategy for Equipment, Cleanroom and Utilities.
• Ensures that all Engineering system changes follow Site Change Control procedures.
• Ensures appropriate use of Risk Management tools to drive Aseptic performance/ Sterility Assurance
• Supports regulatory audits as Aseptic/ Sterility Assurance Engineering system subject matter expert.
• Participates and provides leadership to the Site Aseptics team, highlighting and leading the introduction of continuous improvement initiatives.
• Drives a high-performance culture in Aseptic Manufacturing.  Drives a culture of Speak-Up.

• Participates in routine leadership GEMBAs of Manufacturing and Testing areas.
• Provides key input into Site Contamination Control Strategy, APS Strategy, Aseptic Manufacturing processes.