Lead - Manufacturing Operations Systems

Role Summary

The Manufacturing Operations Systems Lead will report to an Associate Director of Packaging Operations. The role is responsible for owning initiatives and process improvements, acting as a liaison between operations and multiple functional groups to support event management, change controls, and related activities. The Lead will 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 areas.
• 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.
• Participate and/or lead cross functional teams in the development and implementation of strategies associated with the area for Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).
• Identify changes required for MES and ensure they are implemented consistently with operational practices.
• Work with EWM, IDS and Master Data Team to support launch and ticket builds.
• Lead training and troubleshooting for operations.
• Work closely with Logistics on the release of orders.
• Understand and influence the manufacturing control strategy for their area.
• Trained as a Deviation 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.

Qualifications

• High School Diploma or equivalent.
• Experience: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals.
• Technical or Science degree preferred.
• Experience with cGMP environment.
• Experience with EWM and SAP environments and transactions.
• Career interests in Operations Leadership.
• Device Assembly or Packaging experience.
• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals.
• Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
• Excellent interpersonal, written and oral communication skills.

Education

• High School Diploma or equivalent (required).
• Technical or Science degree (preferred).

Additional Requirements

• Ability to travel up to 10%.
• Must be flexible to attend meetings or support off-shifts (operations is 24/7).