Senior Manager, Process Engineering

NovartisDurham, CA
$114,100 - $211,900Onsite

About The Position

At Novartis, you will play a key role in shaping the future of biologics manufacturing. As a Senior Manager, Process Engineering, you will lead a team of engineers responsible for the lifecycle engineering of process and laboratory equipment, with a strong focus on equipment design, system integration, commissioning, qualification, and operational readiness. This role plays a critical leadership role in the startup of a new large molecule manufacturing facility, supporting equipment specification, installation, and qualification to ensure successful delivery of manufacturing capability. Following site startup, you will transition to driving ongoing process equipment performance, continuous improvement, and lifecycle optimization, ensuring systems remain reliable, compliant, and aligned with Good Manufacturing Practice requirements.

Requirements

  • Bachelor’s degree in Chemical, Biochemical, Mechanical, or related engineering field with 9+ years relevant experience
  • Experience in process engineering or manufacturing science within biologics or pharmaceutical manufacturing environments
  • Expertise supporting large-scale biologics manufacturing equipment, including upstream or downstream process systems
  • Experience with equipment design, commissioning, and qualification, delivering systems from concept through operational readiness
  • Experience working with custom-engineered equipment supporting biotechnology processes, including integration and performance evaluation
  • Experience supporting facility startup, expansion, or technology transfer in a regulated manufacturing environment
  • Strong knowledge of Good Manufacturing Practice and regulatory requirements for biologics manufacturing systems
  • Ability to analyze process and equipment performance data to drive optimization, troubleshooting, and continuous improvement

Nice To Haves

  • Experience supporting large-scale biologics manufacturing, including upstream or downstream process systems
  • Experience supporting stainless based equipment manufacturing facilities for large-scale biologics production

Responsibilities

  • Define and evolve lifecycle engineering strategies for large-scale biologics process and laboratory equipment
  • Lead design, configuration, and integration of custom-engineered manufacturing systems supporting biotechnology processes
  • Oversee commissioning and qualification activities to ensure equipment readiness, compliance, and operational performance
  • Provide technical expertise on biologics process equipment across upstream and downstream manufacturing systems
  • Partner with Manufacturing Science and Technology, Operations, and Quality on process performance and technology transfer
  • Support startup of new manufacturing facility, ensuring successful equipment installation, testing, and qualification
  • Own lifecycle strategies to optimize equipment performance and long-term manufacturing capability
  • Lead root cause investigations and implement sustainable solutions for complex process equipment issues
  • Develop technical specifications including user requirements, functional, and detailed design specifications
  • Drive equipment upgrades and continuous improvement initiatives to support evolving process and capacity needs

Benefits

  • health, life and disability benefits
  • a 401(k) with company contribution and match
  • a variety of other benefits
  • a generous time off package including vacation, personal days, holidays and other leaves
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