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, you will partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise and system ownership to support process operations, focusing on Downstream Process engineering.

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 safely 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
  • 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
  • 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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