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Manufacturing Engineer

2 months ago

Fremont, United States Astrix Full time

Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Manufacturing Engineer to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference


Contract length: 4 months

Pay rate: $43-45/hr.

Location: Fremont, CA


Key Responsibilities:

  • Deliver engineering assistance for daily operations, improvement initiatives, and projects in a GMP-regulated setting
  • Oversee equipment maintenance and troubleshooting, including leading return-to-service plans
  • Diagnose and troubleshoot equipment failures
  • Develop and lead plans to return equipment to service efficiently
  • Work with internal resources to plan and achieve engineering goals.
  • Manage and coordinate repairs with external vendors
  • Develop maintenance strategies and review spare parts inventory
  • Perform equipment testing following maintenance activities
  • Recommend and assess part upgrades and replacements
  • Act as a Subject Matter Expert (SME) in deviation investigations and own CAPA processes
  • Provide feedback and assessments to Process/Automation Engineering


Qualifications:

  • Bachelor's degree in science or engineering
  • 4-10 years of relevant work experience in a biopharmaceutical or GMP-regulated environment
  • Experience as an equipment engineer working with corrective and preventative action
  • Extensive knowledge of biopharma processes and equipment, including upstream cell culture, downstream purification, cleaning-in-place, and freezing operations
  • Strong ability to collaborate with Maintenance, Instrumentation, Automation, and Engineering teams
  • Solid understanding of process control systems
  • Ability to lift to 50 lbs. with assistance.