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Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 2 - Sterile Filling

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

About the Job

Requirements

  • Prior experience in a regulated manufacturing environment.
  • Ability to read, write, speak, and understand English to interpret standard operating procedures, batch records, and work instructions.
  • Demonstrated documentation and data-entry skills, including accurate completion of batch records and logbooks.
  • Basic mathematical skills, including routine calculations involving weights, measures, and conversions.
  • Ability to follow written procedures and work instructions with minimal supervision and escalate issues as needed.
  • Basic problem-solving skills and ability to identify process or documentation deviations and inconsistencies.
  • Ability to work effectively as part of a team in a fast-paced production environment.
  • Ability to perform the physical demands of the role, including climbing, kneeling, standing, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
  • Ability to observe visual details, work with data and figures, view a computer terminal, read extensively, operate machinery, and make general observations of facilities.
  • Ability to follow handling precautions for potential exposure to area chemicals.
  • Ability to participate in an occupational health program, which may 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.
  • Ability to adhere to the Quality Management System, including the Quality Manual, Quality Policy, standard operating procedures, current Good Manufacturing Practices, and applicable regulations and standards.
  • Ability to pass an eye exam during onboarding.
  • Ability to demonstrate and maintain gown qualification standards.

Responsibilities

  • Operate assigned machinery by 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 supervisory control and data acquisition systems and human-machine interfaces.
  • Work with printing devices, including printing mats.
  • Perform cleaning and housekeeping activities for assigned areas to maintain a current Good Manufacturing Practices environment.
  • Perform visual and physical checks of in-process and finished materials as requested.
  • Follow aseptic behaviors, participate in media fills including line interventions, and maintain basic knowledge of viable and non-viable monitoring equipment.
  • 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.
  • Identify and suggest process improvements while maintaining quality and current Good Manufacturing Practices compliance.
  • Complete batch record and Good Manufacturing Practices documentation entries and maintain required records and logs, including mathematical computations where needed.
  • Perform inventory control and reconciliation activities using SAP in a limited role.
  • Acquire and maintain required certifications and qualifications for the assigned work area, including aseptic gowning qualification.
  • Cross-train and support other work areas as needed.
  • Attend and actively participate in daily tier meetings.

Desired Qualifications

  • High school graduate, vocational school graduate, or equivalent.
  • At least 1 year of experience in a pharmaceutical, biotechnology, or current Good Manufacturing Practices-regulated manufacturing environment.
  • Working knowledge of current Good Manufacturing Practices principles, including documentation practices, safety procedures, and compliance expectations.
  • 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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