Jobs · Management · Indiana

Engineer - Process

BioSpace · Indianapolis, IN · 3 wk ago
Management$66k–$172k/yrFull-time

About the role

The Engineer – Process is responsible for establishing and maintaining the reliable operation and qualified state of the equipment and business processes in the area they support. They engage with cross-functional support teams as an equipment/automation subject matter expert to ensure the business meets defined safety, quality, and productivity goals.

Core Responsibilities

  • Ensure a safe working environment by following safety rules and helping improve safety culture.
    • Participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvements.
  • Responsible for the safe design and safe operation of the equipment within the area.
    • Ensure that systems/solutions are in-control, compliant, and capable of meeting customer needs, while delivering projects associated with regulatory compliance, commercialization, capacity, and continuous improvement efforts.
  • Demonstrate technical expertise of processes/equipment in area of responsibility, including clear understanding of equipment flow, process flow, critical process parameters, and standard operating procedures for the processes.
    • Lead troubleshooting efforts to resolve difficult equipment and operational issues.
    • Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve and communicate equipment issues.
    • Engage with original equipment manufacturers and other service vendors to build knowledge base and deliver on projects and troubleshooting efforts.
  • Communicate effectively with others, especially project team members, process team members, operations, maintenance, and crafts personnel.
    • Perform impact assessments for varying levels of changes to responsible equipment/systems.
    • Establish control systems and monitor/trend, as tools to verify and optimize equipment performance.
    • Understand equipment reliability issues with the objective of process improvement.
    • Identify and drive improvements associated with equipment within the area.

Basic Qualifications

  • Bachelor’s degree in an engineering field, with preference to Mechanical or Electrical Engineering disciplines.
  • 1+ years of engineering experience in a GMP or highly regulated environment.

Additional Skills/Preferences

  • Experience in pharmaceutical manufacturing, parenteral, and/or packaging processes.
  • Experience in Commissioning & Qualification, asset delivery, validation activities, and cGMP regulations.
  • Demonstrated ability to communicate effectively to customers, business partners, and staff including good oral, written, and visual presentations.
  • Experience utilizing and implementing various tools, systems, and processes resulting in improved operational excellence.

Organization Overview

Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. Our employees unite caring with discovery to make life better for people around the world. We are committed to equal opportunity employment and providing a supportive workplace for all employees.

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