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Resilience

Biologics and sterile injectables CDMO

Maintenance Technician 4 - Idap

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

About the Job

Requirements

  • Demonstrated experience performing corrective, preventative, and predictive maintenance on automated process equipment in a regulated GMP environment.
  • Demonstrated mechanical and electrical troubleshooting proficiency, including mechanics, hydraulics, pneumatics, and electronics.
  • Familiarity with controlled (CNC) manufacturing environment requirements, including gowning, environmental monitoring awareness, and clean room behavior.
  • Ability to independently diagnose and resolve equipment failures with limited supervision and make independent decisions regarding own maintenance work.
  • Proficiency in Computerized Maintenance Management Systems (CMMS), such as Maximo or SAP, including independently creating, updating, and closing work orders.
  • Demonstrated ability to complete and review GMP documentation accurately, including work orders, batch records, and maintenance logs per cGMP requirements.
  • Ability to read and interpret electrical schematics, mechanical drawings, and equipment manuals.
  • Ability to understand, read, write, communicate, and follow instructions in English.
  • Ability to meet the physical requirements of a primarily non-sedentary role, including climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
  • Visual acuity for working with data and figures, viewing computer terminals, extensive reading, operating machinery and motor vehicles, and general facility observations.
  • Participation in an occupational health program, which may include medical assessment, surveillance, vaccination, and testing.
  • Ability to use personal protective equipment, which may include respirators, powered air-purifying respirators, gowns, gloves, face protection, and other barrier equipment.
  • Ability to adhere to the Quality Management System, including the Quality Manual, Quality Policy, Standard Operating Procedures, current Good Manufacturing Practices, and other regulations and standards applicable to the role.

Responsibilities

  • 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 according to established procedures and timelines.
  • Monitor data to maintain equipment and system performance within the assigned operating area.
  • Use testing, tools, and measuring equipment to maintain and troubleshoot electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment.
  • Install new equipment and oversee equipment upgrades according to site standard operating procedures.
  • Perform 5S activities and maintain organization of operating areas.
  • Identify and prioritize maintenance needs within the assigned operating area, working with limited supervision and coordinating with the Maintenance Facilitator, Process Facilitator, Engineer, or other activity leads.
  • Perform Technician and Mechanical Technician duties as required to support daily PET activities.
  • Use problem-solving and troubleshooting techniques to complete equipment repairs.
  • Serve as a project resource to PET, supporting timely project follow-up and implementation and validation activities.
  • Perform cleaning and housekeeping activities in assigned areas to maintain a cGMP environment.
  • Complete documentation and required work-order-system functions to close activities in compliance with cGMPs.
  • Perform work in accordance with standard operating procedures, cGMPs, and established safety procedures and OSHA requirements and guidelines.
  • Maintain familiarity 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.
  • Follow and maintain compliance with MRO procedures and inventory control.
  • Train operators in equipment setup and minor adjustments or repairs.
  • Maintain gowning and controlled-environment certifications as required for assigned work areas.
  • Work the expected 12-hour night shift on a 2/2/3 schedule, from 6:00 p.m. to 6:30 a.m.; schedules may be modified and overtime may be requested based on business and operational needs.

Desired Qualifications

  • High school diploma or GED, associate degree, or vocational/trade school certification in a relevant discipline such as industrial maintenance, electrical, mechanical, or instrumentation.
  • Four or more years of equipment maintenance experience in a regulated pharmaceutical or GMP manufacturing environment.
  • Experience with OEE, TPM, LEAN, or other continuous-improvement methodologies.
  • Knowledge of data and materials systems such as Maximo, SAP, ADP, KRONOS, or other MRP/ERP systems.
  • Experience with automated pharmaceutical manufacturing equipment, such as inspection, assembly, packaging, or filling equipment.

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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