Aseptic Manufacturing Technical Lead

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

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 standardisation by implementing and continually updated aseptic best practices based on events and technological advancements.

Acting collaboratively with the sites organising and executing improvement events that proactively identify, quantify, prioritise & mitigate aseptic risks.

The position will work with sites, the 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.

• 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.
• Organise and execute improvement events at manufacturing sites that proactively identify, quantify, prioritise & mitigate aseptic risks within the sites.
• Act collaboratively with the sites to drive standardisation 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 floor practices, identifying aseptic risks, and facilitating solutions for mitigating those risks.
• Participate in identifying, reporting and tracking site/network aseptic metrics to drive best‑in‑class aseptic performance.

• 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 understanding 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 escalade competing priorities and communicate to applicable stakeholders.
• Must have demonstrated organisational and planning skills and excellent verbal and written communication skills.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to…