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Resilience

Biologics and sterile injectables CDMO

Engineering Technician 4

Equipment MaintenanceConfirmed live in the last 24 hours
Full-timeBlue Ash, OH, USAIn-person

About the Job

Requirements

  • Demonstrated experience maintaining and improving automated production equipment in a regulated manufacturing environment such as cGMP.
  • Experience and knowledge of ladder logic, with the ability to navigate programmable logic controller programs to isolate faults.
  • Demonstrated ability to lead troubleshooting on automated production equipment and drive an issue to root cause.
  • Training in mechanics, hydraulics, pneumatics, and electronics, including use of testing equipment for electrical and mechanical troubleshooting.
  • Experience with computerized maintenance management systems such as SAP, including work order documentation and established maintenance, repair, and operations procedures for inventory control.
  • Ability to read and interpret diagrams, drawings, piping and instrumentation diagrams, electrical schematics, and other technical documentation.
  • Ability to self-direct daily work based on area business needs and make independent decisions within the role's scope, escalating novel or cross-functional issues to the Area Leader or Process Execution Team Engineer.
  • Ability to effectively understand, read, write, communicate, and follow instructions in English.
  • Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair.
  • Ability to stand, walk, bend, kneel, climb ladders, and work in confined or elevated spaces for extended periods across a 12-hour shift.
  • Ability to wear gowning, sterile garments, and personal protective equipment as required by activities and classified area requirements.
  • Ability to work in and around operating production equipment, cleanrooms and classified environments, mechanical spaces, and utility areas.
  • Ability to work with exposure to noise, temperature variation, cleaning agents, and process materials consistent with a cGMP biologics manufacturing facility.

Responsibilities

  • Serve as the escalation point for complex, intermittent, and cross-system faults not resolved by standard maintenance procedures; apply structured problem-solving and troubleshooting techniques to complete repairs and prevent recurrence.
  • Use tools and testing and measuring equipment to complete emergency, corrective, and preventative maintenance on equipment and systems used within the Process Execution Team.
  • Monitor equipment and systems for performance and problem indicators, and act on early signs of degradation before they cause downtime.
  • Work across area automation and data systems, including programmable logic controllers, supervisory control and data acquisition systems, human-machine interfaces, servers, databases, data historians, and visualization platforms.
  • Troubleshoot programmable logic controller, input/output, and vision programs.
  • Implement new programmable logic controller and human-machine interface code and modify existing code under approved change control.
  • Own the area's control system version control, backup, and restoration program, including associated data integrity and compliance requirements.
  • Diagnose and resolve network issues affecting production equipment, including virtual local area network, subnet, and internet protocol faults.
  • Analyze equipment and process data trends to identify root causes, solutions, and improvements.
  • Identify and implement continuous improvement projects in changeover reduction, yield improvement, overall equipment effectiveness improvement, maintenance reliability, and waste reduction.
  • Develop project justifications and engineering proposals, providing input for the capital planning process.
  • Participate in new equipment design by providing input for user requirements, specifications, and documentation required to qualify new equipment and processes.
  • Serve as a project resource for new equipment installations, retrofits, and upgrades, and assist with executing validation protocols for equipment and processes.
  • Lead and coordinate technical investigations and studies, and support deviation investigations with technical assessment of equipment and system contributions.
  • Execute maintenance and technical work in accordance with standard operating procedures, current good manufacturing practices, and Occupational Safety and Health Administration safety requirements, and document work to current good manufacturing practice standards.
  • Complete documentation and required functions within the work order system, and maintain compliance with established maintenance, repair, and operations procedures for inventory control.
  • Train Operators and Maintenance Technicians on systems, software, equipment, machines, procedures, and processes.
  • Provide technical guidance to Operators and Technicians on shift when equipment or system issues arise.

Desired Qualifications

  • Associate degree in engineering or a related discipline, or equivalent mechanical trade school graduate.
  • Three or more years of experience with automated production equipment.
  • Experience with overall equipment effectiveness, total productive maintenance, lean, or other continuous improvement systems.
  • Experience in biologics or sterile drug product manufacturing.
  • Experience with data historian, supervisory control and data acquisition, or visualization platform configuration.

About the Company

Resilience

Biologics and sterile injectables CDMO

Resilience is a North American CDMO focused on biologics and sterile drug products. It provides end-to-end services from development through commercial production, including biologics development and drug substance manufacturing, aseptic fill/finish, device assembly, packaging, logistics, regulatory support, and tech transfer, all coordinated via a stage-gate process and a digital quality management system. It differentiates itself with North American-based, integrated biologics and sterile capabilities, a focus on sterile injectables and device assembly, and recent expansion into injectable pen devices for diabetes and obesity medicines. Its goal is to broaden access to complex medicines while protecting North American biopharma supply chains with dependable capacity and strong regulatory support from clinical development to commercial scale.

Company size
1,001-5,000
Company stage
Growth Equity (Venture Capital)
Total funding
$3.2B
Headquarters
Blue Ash, OH
Founded
2020

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