Aseptic Manufacturing Technical Lead

Aseptic Manufacturing Technical Lead

AbbVie

Sligo, Ireland

Job Description

Purpose:

The Aseptic Manufacturing Technical Lead role will report to the Director of Aseptic Manufacturing.

The Aseptic Manufacturing Technical Lead acts as a technical SME for aseptic processes within the Network Aseptic Manufacturing Global team. The position is responsible for supporting troubleshooting for significant aseptic events within the network by providing hands-on assessments and investigation support. The technical lead will drive standardization by implementing and continually updated aseptic best practices based on events and technological advancements. Acting collaboratively with the sites organizing and executing improvement events that proactively identify, quantify, prioritize & mitigate aseptic risks.

The position will working with sites, aseptic global team, and aseptic training to partner in development and roll out of aseptic training and mentoring for operations leadership in good aseptic processing.

Responsibilities:

• Provide onsite support for investigation for significant aseptic events within the network by providing hands-on assessments and investigation support.
• Proactively mentor, advise, and share best practices with network team members, site peers and senior management.
• Contribute to the development of Aseptic Manufacturing long range strategy and planning and generation of capital plans.
• Organizing and executing improvement events at manufacturing sites that proactively identify, quantify, prioritize & mitigate aseptic risks within the sites.
• Acting collaboratively with the sites to drive standardization by implementing and continually updated aseptic best practices based on events and technological advancements.
• Participate in aseptic auditing by comparing procedures to actual, day-to-day on the floor practices, identifying aseptic risks, and facilitate solutions for mitigating those risks.
• Participate in identifying, reporting, and tracking site/network aseptic metrics to drive best in class aseptic performance.

Qualifications

• Technical bachelor’s degree in Engineering or Science preferred, with other degrees and demonstrated experience with aseptic manufacturing acceptable.
• Minimum 7 years of manufacturing experience within an aseptic manufacturing environment. Must have depth and breadth of knowledge with equipment, process, and technique as related to sterile manufacturing.
• Demonstrated ability to mentor and influence outside of direct reporting relationships.
• Balanced understating between Quality, Compliance, and Manufacturing concerning non-conformity event impact, project capital/expense generation, etc.
• Must have demonstrated knowledge of regulations and standards for aseptic manufacturing and application to a manufacturing environment.
• Ability to problem solve, initiate, and manage projects with demonstrated ability to effectively escalate competing priorities and communicate to applicable stakeholders.
• Must have demonstrated organizational and planning skills and excellent verbal and written communication skills.