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Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 3 - Mechanic, Dap

Machine & Process OperationConfirmed live in the last 24 hours
Full-timeBlue Ash, OH, USA

About the Job

Requirements

  • Prior experience with equipment maintenance, troubleshooting, or preventive maintenance tasks in a manufacturing setting.
  • Progressive experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
  • Strong working knowledge of cGMP regulations, including documentation practices, deviation reporting, and data integrity principles.
  • Demonstrated mechanical and technical aptitude, including the ability to interpret schematics and maintenance manuals.
  • Ability to independently execute procedures and troubleshoot routine equipment and process issues.
  • Ability to independently review and ensure accuracy of batch records, CMMS entries, and controlled documentation.
  • Mathematical skills sufficient to perform routine production and maintenance calculations and verify entries in batch records and CMMS.
  • Ability to read, write, speak, and understand English to interpret technical documents and communicate cross-functionally.
  • Ability to work effectively as part of a team in a fast-paced production environment.
  • Ability to perform non-sedentary work, including climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
  • Ability to pass an eye exam during onboarding.

Responsibilities

  • Operate, monitor, and perform maintenance tasks on various packaging equipment.
  • Perform technician tasks as required, including start-up, equipment operation, manual packaging, and line clearances.
  • Operate light material handling equipment, including motorized and manual pallet jacks and non-motorized lifts.
  • Monitor material quality of incoming, in-process, and finished materials, and promptly escalate concerns.
  • Act as a first-line technical resource for the team and provide technical support to production technicians.
  • Proactively monitor equipment and component conditions and perform preventive maintenance tasks.
  • Interpret technical documents, including schematics and maintenance manuals, to support troubleshooting and repairs.
  • Execute protocols as required for equipment qualification and process validation work.
  • Perform batch records, GMP documentation, and CMMS entries, including mathematical computations as required.
  • Review process documents such as operational SOPs, PM procedures, forms, and batch records for accuracy.
  • Support lean activities and process improvement work, including 5S and problem-solving.
  • Act as a certified OJT trainer on assigned equipment or process tasks.
  • Acquire and maintain all required certifications and qualifications for the assigned work area.
  • Attend and actively participate in daily tier meetings.
  • Adhere to the Quality Management System, including the Quality Manual, Quality Policy, Standard Operating Procedures, current Good Manufacturing Practices, and other applicable regulations and standards.
  • Use required personal protective equipment, which may include respirators, PAPRs, gowns, gloves, face protection, and other barrier equipment.
  • Participate in the occupational health program, which may include medical assessment, surveillance, vaccination, and testing.

Desired Qualifications

  • High school graduate, vocational school graduate, or equivalent.
  • At least 2 years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
  • Experience in a lean manufacturing environment.
  • Prior experience as an equipment OJT trainer.
  • Working knowledge of Microsoft applications, SAP, and/or Veeva Vault.

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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