Sr. Operations Associate

Role Summary

The Sr. Operations Associate (OA) will report to an Associate Director of Packaging Operations. The OA will be responsible for providing leadership within the area’s process team, managing projects and process improvements, acting as a liaison between operations and multiple functional groups to support event management, change controls, etc. The OA will also assist the operations team in the day-to-day management of the production floor and lead investigations and drive implementation of actions associated with deviations.

Responsibilities

• Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Packaging area.
• Monitor and build a strong safety culture
• Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.
• Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area.
• Trained as a Lead Investigator
• Development and monitoring of metrics for the area
• Aid in issue resolution, batch/product approvals, and production schedule execution.
• Lead specific activities of the process teams.
• Potential back-up of Associate Director/Manager

Qualifications

• Required: Bachelor’s degree (or equivalent work experience)
• Required: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals
• Required: Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals
• Required: Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
• Required: Excellent interpersonal, written and oral communication skills
• Required: Ability to travel up to 10%
• Preferred: Technical or Science degree
• Preferred: Previous leadership/supervisory experience helpful
• Preferred: Career interests in Operations Leadership
• Preferred: Device Assembly or Packaging experience

Education

• Bachelors degree (or equivalent work experience in cGMP production)

Additional Requirements

• The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
• Must be flexible to attend meetings or support off-shifts (operations is 24/7)
• Travel up to 10% is required