Process Engineer II

3 weeks ago

West Chester, Ohio, United States RESILIENCE US INC Full time

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.

Key Responsibilities:
  • Ensure one technical process exists within the PET/Facility, including equipment, materials, process, and procedures with applicable validation.
  • Lead improvement initiatives as the technical expert and act as the first line of support for all project-related work.
  • Maintain a strong relationship with Technical Operations and Quality areas, as well as collaborate within the PET/Facility and with other PET Engineers.
  • Serve as the single point of contact for all technical issues.
  • Ensure success criteria for technology transfer and validation are clear and the process is capable for the merge into the PET/Facility process.
  • Manage the life cycle of assets, including maintenance, and perform routine validation and periodic reviews activities.
  • Collaborate with equipment and material suppliers to identify, develop, and implement appropriate change controls to improve processes and address root causes identified in investigations.
  • Perform and maintain risk management activities for new and existing processes/equipment.
  • Author and review documents, including Standard Operating Procedures, Batch Records, Rework procedures, and other forms.
  • Provide engineering and project management services, including developing user requirements for new asset procurement and assisting in the development of project justification and engineering proposals.
  • Support and lead technical trouble shooting, including on-call support as required.

Key qualifications include training or experience in applicable technologies, such as mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical troubleshooting, aseptic/controlled environment, unit operations, formulation, and packaging.

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