Plant Engineer

3 weeks ago


Fremont, United States SPECTRAFORCE Full time

Job Title: Plant Engineer

Location: Fremont, CA 94555

Duration: 3+ months

Shift: 1st Shift: Mon-Friday, 8 am-5 pm


DUTIES:

  • The Plant Engineer will provide Engineering support to the daily operations, continuous improvement, and projects for Drug Substance Manufacturing in a GMP-regulated environment.
  • The resource will abide by the Standard Operating Procedures (SOPs) and GMP regulations for the Engineering support provided.
  • The resource will plan and accomplish goals with guidance from BI internal resources.
  • Primary responsibilities are equipment ownership and front-line equipment troubleshooting.
  • Tasks include:
  • Fielding escalations from and providing direction to Maintenance/ Automation/Instrumentation
  • Troubleshooting down equipment and providing/leading a return-to-service plan
  • Coordinating vendor repairs
  • Maintenance strategy recommendations
  • Spare parts inventory review
  • Post-maintenance equipment testing
  • Part upgrade recommendations (like-for-like assessments)
  • Deviation investigation SME participant
  • CAPA ownership
  • Engineering assessments and feedback to Process/Automation Engineering
  • Work order review.

SKILLS:

  • Technical depth of biopharma processes and equipment, i.e. upstream cell culture, downstream purification, cleaning-in-place, and freezing operations
  • Interpersonal skills to work closely with Maintenance/Instrumentation/Automation/Engineering groups.
  • Understanding of process controls


PHYSICAL DEMANDS:

  • Ability to lift 50 lbs with assistance.


EDUCATION: Bachelor’s degree in science or engineering, plus 4-10 years of relevant work experience


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