Maintenance/Process Engineer-Reliability
Amylin Pharmaceuticals, Inc. - Cincinnati, OH

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Work with Maintenance/MRO Manager to support reliability engineering and equipment improvement efforts in a Pharmaceutical Plant involved in the production of active pharmaceutical ingredients, aseptic filling operations, and finished product packaging and inspection. This position is responsible for developing the overall asset management strategy for assigned equipment.

RESPONSIBILITIES:

Provide technical support for a pharmaceutical manufacturing operation. Responsibilities include:
  • Lead efforts to improve equipment uptime
  • Lead efforts to improve equipment related product yields
  • Lead Root Cause Failure analysis of major equipment failures
  • Identify, analyze and provide sustainable solutions for recurring equipment problems
  • Implement predictive and other non-destructive maintenance methodologies to improve equipment reliability
  • Provide high-level technical support to maintenance technicians
  • Perform Reliability Centered Maintenance (RCM) analyses
  • Become the Subject Matter Expert (SME) on pharmaceutical production equipment (e.g. aseptic filling equipment, active pharmaceutical ingredient manufacturing, pharmaceutical packaging equipment) in assigned areas
  • Determine recommended spare parts for equipment
  • Identify and implement equipment reliability improvement projects
  • Utilize statistical analysis to identify and justify improvement activities
  • Optimize existing Preventive Maintenance program to ensure most cost effective maintenance strategy is employed
  • Work with the project engineering group to ensure the reliability and maintainability of new and modified equipment installations
  • Track and work to improve key equipment performance indicators (OEE, asset maintenance costs, downtime by process area & failure code)
QUALIFICATIONS:
  • B.S. in Engineering (Mechanical, Electrical, or Chemical preferred)
  • 3-5 years experience in a technical engineering role, as an SME for a complex manufacturing process
  • Implementation of RCM tools and methodologies
  • Experience in a cGMP pharmaceutical manufacturing environment preferred
  • Ability to work and communicate well with technicians
  • Knowledge of process improvement tools (e.g. Lean, Six Sigma, 5S)
  • In-depth knowledge of CMMS
  • Ability to collect and analyze equipment and maintenance performance data
  • Practical experience with Vibration analysis, Thermal Imaging, Ultrasonic and other PdM technologies
  • Strong leadership and influencing skills.
  • Ability to communicate with all levels of the organization.
  • Good computer skills
REQUIREMENTS

Physical Demands
Up to 20% travel required.

Manual Dexterity
Unimpaired Manual dexterity
Frequently use a computer keyboard, PDA or other electronic or laboratory equipment or devices.

Audible/Visual Demands
Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment
Office, Laboratory and Manufacturing environment

Amylin Pharmaceuticals, Inc. - 22 months ago - save job