Sr Engineer I - 2º Shift

Lifelancer
Any Location, NC
Category Engineering
Job Description
Join Amgen's Mission of Serving Patients. As a Sr Engineer I - 2o Shift, you will partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production.

Requirements

  • Provide system ownership for Biopharmaceutical process equipment
  • Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems
  • Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations
  • Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order
  • Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations
  • Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors
  • System guidance to identify performance risks and implement risk reduction strategies
  • Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
  • Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
  • Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations
  • Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems
  • Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment
  • Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs

Benefits

  • Comprehensive employee benefits package
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models
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