R

Resilience

Biologics and sterile injectables CDMO

Manufacturing Technician 2 - Sterile Filling

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

About the Job

Requirements

  • Prior experience in a regulated manufacturing environment.
  • Ability to effectively 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 performing routine calculations such as weights, measures, and conversions.
  • Ability to follow written procedures and work instructions with minimal supervision, escalating issues as needed.
  • Basic problem-solving skills and 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 obtain and maintain required certifications and qualifications for the assigned work area, including aseptic gowning qualification.
  • Ability to work in controlled/non-classified and classified cleanroom production areas requiring aseptic gowning, and to meet the stated physical demands, including climbing, kneeling, standing, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
  • Ability to handle potential exposure to area chemicals according to standard operating procedures.
  • Ability to use personal protective equipment, which may include respirators, powered 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.
  • Adhere to the established Quality Management System, Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and other applicable regulations and standards.

Responsibilities

  • Operate 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 required data online, including Supervisory Control and Data Acquisition (SCADA) and Human-Machine Interface (HMI) entries.
  • Work with various printing devices, including printing mats.
  • Perform cleaning and housekeeping activities for assigned areas to maintain a Current Good Manufacturing Practice environment.
  • Perform visual and physical checks of in-process and finished materials as requested.
  • Apply 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 provide process-improvement suggestions while maintaining quality and Current Good Manufacturing Practice compliance.
  • Perform batch-record and Good Manufacturing Practice documentation entries; maintain records and logs as required, including mathematical computations where needed.
  • Perform inventory-control and reconciliation activities using SAP in a limited role.
  • 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 Practice-regulated manufacturing environment.
  • Working knowledge of Current Good Manufacturing Practice 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

Recently Posted Jobs

Explore more opportunities at Resilience

See more jobs