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Elanco

Global animal health pharmaceutical company

Manufacturing Process Engineer

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeElwood, KS, USANo salary listed

About the Job

Requirements

  • A bachelor's degree in Chemical, Biological, or a related engineering discipline.
  • Experience in the pharmaceutical, biotechnology, or a related/relevant industry.
  • Working knowledge of current Good Manufacturing Practice (cGMP) standards and/or experience working in a regulated environment.
  • Ability to work, prioritize, and deliver results with minimal supervision.

Responsibilities

  • Provide engineering support for routine operations and capital projects by troubleshooting equipment and process issues, assisting manufacturing teams on the floor, documenting problems in the quality management system, performing root cause analysis, and implementing corrective and preventive actions.
  • Maintain process equipment in a qualified state and ensure systems are fit for intended use and compliant with cGMP standards, company policies, and regulatory requirements.
  • Oversee interventions, maintenance, and changes, ensuring activities are documented and managed through formal change control procedures.
  • Use data to monitor equipment and process performance, evaluate system capacity, identify improvement opportunities, and implement enhancements to optimize productivity, reduce variability, and maintain consistent system control.
  • Contribute to the design, development, execution, commissioning, qualification, and validation of capital projects.
  • Define project scope, evaluate design alternatives, select equipment, develop user requirements, oversee construction, and support process validation activities.
  • Prepare, review, and update user requirement specifications, process and instrumentation diagrams, safety and environmental assessments, and qualification protocols.
  • Collaborate cross-functionally to identify risks, drive value engineering, and improve the technical and financial success of projects.
  • Provide process support during rotating weekend coverage for ongoing operations.

Desired Qualifications

  • At least 2 years of experience in the pharmaceutical, biotechnology, or a related industry.
  • Experience in capital project design, development, and execution.
  • Understanding of monoclonal antibody or recombinant protein manufacturing processes.
  • Experience with SAP EAM, ERP, AutoCAD, Veeva Vault, AVEVA PI, Seeq, or Meridian.
  • Understanding and application of root cause investigation (RCI), failure mode and effects analysis (FMEA), and quality risk management (QRM) tools.
  • Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

About the Company

Elanco

Global animal health pharmaceutical company

Elanco is a global animal health company that develops and sells medicines, vaccines, and preventive care products for livestock and pets. Its portfolio includes prescription medicines, vaccines, parasite controls, and other welfare products used by veterinarians, farmers, and pet owners to prevent or treat disease and improve wellbeing. Since becoming independent after separating from Eli Lilly and acquiring Bayer Animal Health in 2020, it ranks as the world’s second-largest animal health company with a broad, globally distributed product line and direct-to-consumer capabilities. Its goal is to improve animal health and welfare worldwide by providing effective, accessible products and services while growing sustainably.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Indianapolis, IN
Founded
1954

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