Aseptic Manufacturing Technical Lead

AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn 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 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.

• 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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 participate in our short-term incentive programs.
  

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html