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Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 3 - Mechanic, Visual Inspection

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

About the Job

Requirements

  • Prior experience in a regulated production environment, specifically responsible for equipment maintenance and performance.
  • 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.
  • Strong mechanical and electronic knowledge and aptitude.
  • Ability to interpret technical documents.
  • Ability to work in and adapt to a changing and demanding environment.
  • Some overtime may be required with minimal advance notice to support business needs.

Responsibilities

  • Operate, monitor, troubleshoot, and perform maintenance tasks on visual inspection equipment.
  • Work collaboratively with technical resources to resolve equipment issues as needed.
  • Act as a first-line technical resource for the team and provide technical support to production technicians. Resolve equipment-related issues, including equipment start-up, machine recipe selection, recipe format set-up, critical sensor challenge, and production issues.
  • Proactively monitor equipment and perform preventative maintenance tasks. Identify and investigate abnormal conditions and potential defects to prevent unplanned equipment downtime.
  • Perform technician tasks as required, including start-up, equipment operation, manual inspection, batch execution, material handling, rework, cleaning, housekeeping, and line clearance activities.
  • Operate light material handling equipment, including motorized and manual pallet jacks and non-motorized lifts, as needed to safely move, store, or deliver material to the proper location.
  • Monitor material quality of incoming, in-process, and finished materials. Promptly escalate concerns to the Lead Technician and Manager or Supervisor as needed.
  • Perform batch records, GMP documentation, and CMMS entries. Perform mathematical computation as needed.
  • Follow job-related safety procedures and address hazards including PPE, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. Report discrepancies to the process facilitator.
  • Perform work in accordance with SOPs, cGMPs, and established safety and quality procedures.
  • Support lean activities and process improvement work, including performing 5S in the work area, participating in problem-solving, and manually tracking performance data for OEE and process improvement analysis. Lead Level 0 problem-solving on equipment-related issues as needed.
  • Act as a certified OJT trainer on assigned equipment or process tasks. Train and conduct evaluations of other team members for training qualifications.
  • Review process documents, including operational SOPs, PM procedures, forms, and batch records, for accuracy. Identify and suggest process improvements while maintaining quality and cGMP compliance.
  • Execute protocols as required for equipment qualification and process validation work.
  • Support other work areas within the Process Execution Team as needed.
  • Perform other assigned duties with minimal supervision under the direction of the process facilitator or designee.
  • Acquire and maintain required certifications and qualifications for the assigned work area.

Desired Qualifications

  • High school graduate, vocational school graduate, or equivalent.
  • Minimum three years of experience in a regulated production environment, specifically responsible for equipment maintenance and performance.
  • Previous experience with automated equipment.
  • Training in mechanics, hydraulics, and electronics systems.
  • Knowledge of a computerized maintenance management system such as SAP.
  • Experience with OEE, TPM, LEAN, or other continuous improvement methodology.

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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