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Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 3 - Sterile Filling, Day Shift

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

About the Job

Requirements

  • Progressive experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including independent execution of filling procedures.
  • Strong working knowledge of cGMP regulations, including deviation reporting, change control, and data integrity principles.
  • Ability to independently execute complex procedures and troubleshoot routine process or equipment issues.
  • Ability to read, write, speak, and understand English to interpret technical documents and communicate cross-functionally.
  • Attention to detail and demonstrated accuracy in completing and reviewing batch records and controlled documentation.
  • Proficient mathematical and analytical skills, including performing calculations related to manufacturing processes and verifying results.
  • Experience mentoring or training technicians and supporting onboarding of new team members.
  • Ability to identify process improvements and contribute to continuous improvement initiatives.
  • Organizational skills and ability to prioritize tasks while maintaining compliance and production timelines.
  • Ability to work effectively as part of a team in a fast-paced production environment.
  • Ability to work in controlled and classified cleanroom production areas requiring aseptic gowning, perform physically demanding tasks, and handle area chemicals according to SOP precautions.
  • Ability to pass an eye exam during onboarding.
  • Ability to demonstrate and maintain gown qualification standards.
  • Ability to work the 12-hour 2/2/3 night shift schedule; the company may modify schedules and request overtime based on business needs.
  • Work authorization or visa sponsorship is not available for this position.

Responsibilities

  • Independently operate assigned machinery, service filling machines with materials, remove finished materials from machine tables, and maintain smooth product flow.
  • Assemble, disassemble, operate, and sanitize filling equipment.
  • Perform filter integrity testing as needed according to SOP.
  • Start up equipment and make minor adjustments as needed.
  • Enter required data online, including SCADA and HMI entries.
  • Work with printing devices, including printing mats.
  • Perform cleaning and housekeeping activities in assigned areas to maintain a cGMP environment.
  • Perform requested visual and physical checks of in-process and finished materials.
  • Demonstrate advanced aseptic technique; lead and participate in media fills, including line interventions; and apply working knowledge of viable and non-viable environmental monitoring.
  • Assist mechanical staff with preventive maintenance procedures as required.
  • Assist with executing validation and engineering protocols for processes and equipment.
  • Support lean activities and process improvement work, including 5S and problem-solving.
  • Perform SAP transactions at an intermediate level of knowledge as required.
  • Complete batch record and GMP documentation entries, and independently review documentation for accuracy before submission.
  • Identify and provide process improvement suggestions while maintaining quality and cGMP compliance.
  • Act as a certified OJT trainer on assigned equipment and process tasks; train and evaluate Technician II team members.
  • Maintain required certifications and qualifications for the assigned work area.
  • Cross-train and support other work areas as needed.
  • Attend and actively participate in daily tier meetings.
  • Adhere to the Quality Management System, Quality Manual, Quality Policy, SOPs, cGMP, and other applicable regulations and standards.

Desired Qualifications

  • High school graduate, vocational school graduate, or equivalent.
  • At least 2 years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
  • Prior aseptic manufacturing experience.
  • Experience working in a lean manufacturing environment.
  • Working knowledge of Microsoft applications, SAP, and/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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