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Resilience

Biologics and sterile injectables CDMO

Maintenance Technician 4 Lead

Equipment MaintenanceConfirmed live in the last 24 hours
Full-timeWest Chester Township, OH, USAIn-person

About the Job

Requirements

  • Significant experience in a regulated production environment, specifically responsible for equipment maintenance and performance.
  • Must be able to effectively understand, read, write, communicate, and follow instructions in English.
  • Must be able to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair.
  • Must be proficient with computerized maintenance management systems such as Maximo or SAP.
  • Must be able to lead a small team of technical resources in a cGMP environment.

Responsibilities

  • Lead efforts to complete emergency repair, rebuilding, changeover, and inspection work on process-related equipment; install, inspect, test, adjust, repair, and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner.
  • Complete and review documentation and required functions in the work order system to close out activities in compliance with cGMPs.
  • Monitor data within the assigned operating area and maintain equipment and system performance.
  • Use testing, tools, and measuring equipment to maintain and troubleshoot electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment.
  • Train operators and Process Maintenance Technicians in equipment setup and major and minor adjustments or repairs.
  • Lead equipment installation and oversee equipment upgrades according to site SOPs.
  • Lead and perform 5S activities and maintain organization of operating areas.
  • Perform work in accordance with SOPs, cGMPs, and established safety procedures, including OSHA requirements and guidelines.
  • Be familiar with Material Safety Data Sheets for area chemicals.
  • Complete batch record and GMP documentation entries and maintain required records and logs, including mathematical computations where needed.
  • Perform Technician and Mechanical Technician duties as required to support daily PET activities.
  • Teach appropriate problem-solving and troubleshooting techniques for completing equipment repairs.
  • Follow and maintain compliance with established MRO procedures and inventory control.
  • Serve as a project resource to PET to assist with follow-up and timely implementation of projects and validation activities.
  • Maintain aseptic processing and gowning certifications as required for assigned work areas.
  • Perform cleaning and housekeeping activities for assigned areas to maintain a cGMP environment.
  • Perform other similar and related responsibilities as assigned by area management.
  • Work overtime with prior notice as required to support business needs; emergency overtime may be required with little notice to ensure equipment operation.

Desired Qualifications

  • High school graduate, vocational school graduate, or equivalent.
  • Associate degree in engineering or a related discipline, or equivalent mechanical trade school graduate.
  • Previous experience with automated equipment.
  • Training in mechanics, hydraulics, electronics, and testing equipment in electrical and/or mechanical troubleshooting.
  • Knowledge of data and materials maintenance systems such as Maximo, SAP, ADP, KRONOS, or other MRP systems.
  • Experience with OEE, TPM, LEAN, or other continuous improvement systems.
  • Planning and scheduling knowledge.
  • Previous leadership experience in a manufacturing environment.

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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