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Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 4 Lead - Dap

Machine & Process OperationConfirmed live in the last 24 hours
Full-timeWest Chester Township, OH, USAIn-person

About the Job

Requirements

  • Significant experience in a pharmaceutical, biotechnology, or current Good Manufacturing Practice-regulated manufacturing environment.
  • Advanced knowledge of current Good Manufacturing Practice requirements and quality systems, including deviations, change control, and data integrity.
  • Ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members in a fast-paced production environment.
  • Ability to review critical Good Manufacturing Practice documentation and batch records and ensure their accuracy.
  • Ability to work with limited supervision, independently determine daily priorities, and use organizational, analytical, and problem-solving skills to make informed decisions under pressure.
  • Quantitative skills sufficient to interpret production data, evaluate trends, and support investigations and continuous improvement work.
  • Experience providing on-the-job training to peers in a manufacturing environment.
  • Ability to read, write, speak, and understand English to communicate technical information cross-functionally.
  • Ability to work effectively as part of a team in a fast-paced production environment.
  • Ability to meet the physical demands 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 observation.
  • Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
  • Ability to use required 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 relevant to the role.
  • Ability to pass an eye exam during onboarding.

Responsibilities

  • Lead and monitor complex process activities to ensure successful production-floor operations.
  • Perform technician tasks as required, including start-up, equipment operation, manual packaging, and line clearances.
  • Perform inventory control and reconciliation activities using SAP and WES.
  • Execute protocols as required for equipment qualification and process validation work.
  • Ensure production-floor work requirements are followed in accordance with Standard Operating Procedures and current Good Manufacturing Practices.
  • Support lean activities, including 5S, problem-solving, and serving as a continuous-improvement project resource.
  • Make advanced-level batch record and Good Manufacturing Practice documentation entries on the production floor, including complex or non-routine documentation, and guide team members on documentation accuracy.
  • Review operational Standard Operating Procedures, forms, and batch records for accuracy; propose revisions and update documents as needed.
  • Maintain all required certifications and qualifications for the assigned work area.
  • Serve as a technical resource and subject-matter support for production and mechanical technicians.
  • Act as a certified on-the-job trainer for assigned equipment and process tasks, training and supporting team members.
  • Collaborate with Management and Engineers on packaging-floor initiatives.
  • Make independent decisions and guide team members on daily operational activities using problem-solving and prioritization skills.
  • Prepare and lead daily Tier 0 meetings.

Desired Qualifications

  • High school graduate, vocational school graduate, or equivalent.
  • At least four years of experience in a pharmaceutical, biotechnology, or current Good Manufacturing Practice-regulated manufacturing environment.
  • Prior experience serving as a subject-matter resource or trainer on the production floor.
  • Experience in a lean manufacturing environment.
  • Working knowledge of Microsoft applications, SAP and/or Veeva Vault, and generative AI language tools such as Claude.

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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