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Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 2 - Dap

Machine & Process OperationPosted on Nov 10
Full-timeWest Chester Township, OH, USA

About the Job

Requirements

  • Prior experience in a regulated manufacturing environment.
  • Working knowledge of product security controls and material handling equipment.
  • Demonstrated documentation and data-entry skills, including accurate completion of batch records and logbooks.
  • Basic mathematical skills, including the ability to perform routine calculations such as weights, measures, and conversions.
  • Ability to effectively read, write, speak, and understand English to interpret standard operating procedures, batch records, and work instructions.
  • Ability to follow written procedures and work instructions with minimal supervision and escalate issues as needed.
  • Basic problem-solving skills and the ability to identify deviations or inconsistencies in processes or documentation.
  • Ability to work effectively as part of a team in a fast-paced production environment.
  • Ability to perform a primarily non-sedentary role that may include 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 observation of facilities.
  • Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
  • Ability to use personal protective equipment, including respirators, personal air-purifying respirators, gowns, gloves, face protection, and other barrier equipment.
  • Adherence to the Quality Management System, Quality Manual, Quality Policy, standard operating procedures, current Good Manufacturing Practices, and other applicable regulations and standards.
  • Ability to pass an eye exam during onboarding.

Responsibilities

  • Operate assigned machinery by servicing machines with materials, monitoring equipment status, reintroducing materials, manually palletizing finished materials, and ensuring smooth product flow.
  • Start up machinery, including equipment setup, recipe selection, data entry on SCADA and HMI, minor adjustments, and critical sensor challenges.
  • Perform manual packaging tasks, including hand packaging and rework of in-process and finished material.
  • Operate light material-handling equipment, including motorized and manual pallet jacks and non-motorized lifts, to safely move, store, or deliver material.
  • Perform visual quality inspections and sampling of in-process materials, and promptly escalate concerns to the Lead and Management.
  • Perform minor troubleshooting, including clearing minor jams and identifying equipment defects, and escalate issues to the Lead and Management.
  • Perform inventory control and reconciliation activities using SAP and WES.
  • Perform cleaning, housekeeping, and line-clearance activities in assigned areas to maintain a current Good Manufacturing Practices environment.
  • Complete batch-record and Good Manufacturing Practices documentation entries and perform mathematical computations as required.
  • Follow job-related safety procedures covering personal protective equipment, lockout/tagout, ergonomics, material, chemical and waste handling, spill controls, and human safety.
  • Support lean activities and process-improvement work, including 5S, problem-solving, and manual data collection.
  • Execute protocols as required for equipment qualification and process-validation work.
  • Provide flexible support to other areas of the Manufacturing Team as needed.
  • Acquire and maintain required certifications and qualifications for the assigned work area.
  • Attend and actively participate in daily Tier 0 meetings.
  • Work the 2-2-3 schedule on 12-hour shifts from 6:00 p.m. to 6:30 a.m.; work schedules may be modified and overtime may be requested based on business needs.

Desired Qualifications

  • High school graduate, vocational school graduate, or equivalent.
  • At least one year of experience in a pharmaceutical, biotechnology, or current Good Manufacturing Practices-regulated manufacturing environment.
  • Experience working in a lean manufacturing environment.
  • Working knowledge of current Good Manufacturing Practices principles, including documentation practices, safety procedures, and compliance expectations.
  • Working knowledge of Microsoft applications, SAP, 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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