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Resilience

Biologics and sterile injectables CDMO

Automation Engineer 2

Controls & Automation EngineeringConfirmed live in the last 24 hours
Full-timeWest Chester Township, OH, USAIn-person

About the Job

Requirements

  • Experience supporting manufacturing operations in a regulated or current good manufacturing practice (cGMP) environment.
  • Experience with some of the following automation systems: programmable logic controllers (PLCs), human-machine interfaces (HMIs), and supervisory control and data acquisition (SCADA), including Rockwell, Inductive (Ignition), Aveva (Wonderware), Siemens, Emerson (GE), or B&R.
  • Ability to work independently and pay attention to detail, with a desire to learn about manufacturing technologies.

Responsibilities

  • Participate in and support the design, optimization, commissioning, or validation of newly procured or existing equipment as the automation lead.
  • Interface with equipment and systems including PLCs, SCADAs, HMIs, servers, databases, data historians, visualization systems, and other automation equipment.
  • Consult cross-functionally and assist system owners in process development as the automation subject matter expert.
  • Review and approve requirements, specifications, drawings, coding procedures, and guidelines.
  • Provide technical guidance and train others on systems, software, equipment, machines, procedures, or processes.
  • Troubleshoot technical issues and identify temporary and permanent fixes.
  • Review and approve documentation needed to qualify equipment and processes.
  • Author, review, and revise standard operating procedures (SOPs) and specifications to maintain equipment, systems, or facilities, and comply with all SOPs.
  • Ensure proper documentation practices during maintenance processes.
  • Recommend and initiate activities to ensure areas and equipment remain compliant.
  • Assess and implement improvements in productivity, waste generation, quality, and cost.
  • Lead and coordinate investigations and studies with little supervision.
  • Interact with regulatory agency personnel during audits and inspections.
  • Perform quality audits to ensure devices are in proper working condition.
  • Provide 24/7 support as part of a rotating on-call support system.
  • Perform other tasks as needed or assigned by the supervisor.

Desired Qualifications

  • Experience with FactoryTalk Batch.
  • Experience with data historian and visualization systems such as Aveva PI (OSI PI).
  • Experience with Microsoft SQL database design.
  • Knowledge of GAMP 5 and ISA standards.
  • Knowledge of change control, deviation, corrective and preventive action (CAPA), validation, and qualification principles.
  • Bachelor’s degree in Engineering or Computer Science, or a related discipline.

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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