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Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 3 - Sterile Filling

Machine & Process OperationPosted on Nov 9
Full-timeWest Chester Township, OH, USAIn-person

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 accuracy in completing and reviewing batch records and controlled documentation.
  • Mathematical and analytical skills, including performing manufacturing-process calculations 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 perform non-sedentary production work, including climbing, kneeling, standing, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
  • Ability to safely handle potential exposure to area chemicals according to standard operating procedures.
  • Ability to use required personal protective equipment, including respirators, personal air purifying respirators, gowns, gloves, face protection, and other barrier equipment.
  • Ability to pass an eye exam during onboarding.
  • Ability to demonstrate and maintain gown qualification standards.
  • Ability to work the Day Shift 2/2/3 schedule and accommodate possible schedule changes or overtime based on business needs.

Responsibilities

  • Independently operate all assigned machinery, including servicing filling machines with materials, removing finished materials from machine tables, and assuring smooth product flow.
  • Assemble, disassemble, operate, and sanitize various filling equipment.
  • Perform filter integrity testing as needed according to standard operating procedures.
  • Start up equipment and make minor adjustments as needed.
  • Enter data online as required, including entries in SCADA and HMI systems.
  • Work with printing devices, including printing mats.
  • Perform cleaning and housekeeping activities in assigned areas to maintain a cGMP environment.
  • Perform visual and physical checks of in-process and finished materials as requested.
  • Demonstrate advanced aseptic technique and lead and participate in media fills, including line interventions; 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 performing 5S and participating in 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 suggestions for process improvement while maintaining quality and cGMP compliance.
  • Act as a certified on-the-job trainer for 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, standard operating procedures, current Good Manufacturing Practices, and other applicable regulations and standards.
  • Work in controlled/non-classified and classified cleanroom production areas requiring aseptic gowning.
  • Participate in the occupational health program, which may include medical assessment, surveillance, vaccination, and testing.

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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