Senior Technical Lead

4 days ago

Hamilton, Ohio, United States RESILIENCE US INC Full time

Resilience US INC is a technology-focused biomanufacturing company that's changing the way medicine is made.

We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Job Overview

This role is responsible for leading technical processes and implementing continuous process improvement initiatives. The ideal candidate will have experience in GMP or regulated production environments and training or experience in applicable technologies.

Key Responsibilities
  • Maintain technical processes with clear centerlines, critical process parameters, material fit for use, and operating procedures.
  • Lead changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction efforts for automated pharmaceutical manufacturing equipment.
  • Ensure success criteria for technology transfer and validation is clear and the process is capable for Manufacturing/Facility integration.
  • Generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/reports.
  • Coordinate and support Manufacturing/Facility improvement initiatives defining equipment data, capabilities, utilization, efficiencies, and obsolescence.
  • Manage life cycle of assets and maintain external technical relationships with suppliers.
  • Identify, develop, and manage implementation of change controls to improve processes and address root causes.
  • Perform risk management activities for new and existing processes/equipment.
  • Initiate deviations, investigate impacts, and author/review documents including Standard Operating Procedures and Batch Records.
  • Provide input on user requirements for new asset procurement and assist in project justification and engineering proposals.
  • Support technical training requirements and perform routine validation and periodic reviews.
Requirements
  • Experience in GMP or regulated production environment.
  • Training or experience in applicable technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment, and aseptic/controlled environment unit operations.
Benefits

$120,000 - $180,000 per year

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