Aseptic Manufacturing Technical Lead

Role Summary

The Aseptic Manufacturing Technical Lead acts as a technical subject matter expert for aseptic processes within the Network Aseptic Manufacturing Global team. The role supports troubleshooting for significant aseptic events, provides hands-on assessments and investigation support, and drives standardization by implementing and continually updating aseptic best practices. It collaborates with sites to organize improvement events, identify and mitigate aseptic risks, and partners with training to develop and roll out aseptic training for operations leadership in good aseptic processing.

Responsibilities

• Provide onsite support for investigation of significant aseptic events within the network by delivering hands-on assessments and investigation support.
• Mentor, advise, and share best practices with network team members, site peers, and senior management.
• Contribute to the development of long-range Aseptic Manufacturing strategy, planning, and capital project generation.
• Organize and execute improvement events at manufacturing sites to proactively identify, quantify, prioritize, and mitigate aseptic risks.
• Collaborate with sites to drive standardization by implementing and updating aseptic best practices based on events and technological advances.
• Participate in aseptic auditing by comparing procedures to on-the-floor practices, identify risks, and facilitate mitigation solutions.
• Identify, report, and track site/network aseptic metrics to drive best-in-class aseptic performance.

Qualifications

• Technical bachelor’s degree in Engineering or Science preferred; other degrees with demonstrated aseptic manufacturing experience acceptable.
• Minimum 7 years of manufacturing experience in an aseptic manufacturing environment with depth and breadth of knowledge of equipment, process, and technique related to sterile manufacturing.
• Demonstrated ability to mentor and influence outside of direct reporting relationships.
• Balanced understanding between Quality, Compliance, and Manufacturing regarding non-conformity impact and project capital/expense considerations.
• Knowledge of regulations and standards for aseptic manufacturing and their application to manufacturing environments.
• Ability to solve problems, initiate and manage projects, and effectively escalate competing priorities to applicable stakeholders.
• Strong organizational and planning skills with excellent verbal and written communication.

Education

• Technical bachelor’s degree in Engineering or Science preferred; alternative degrees with relevant aseptic manufacturing experience acceptable.