Principle Engineer I in Novato, CA at Apex Life Sciences

Date Posted: 7/19/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Novato, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/19/2018
  • Job ID:
    868471

Job Description


Apex Life Sciences currently has an opening in Novato, CA as a Principal Engineer that will work onsite at a mid-size Biotech company. The client is looking to bring an experienced engineer to help support various departments that sit on site.

Duties:

  • Technical investigations shall include, and not be limited to, biotechnology literature reviews, product specifications assessments and recommendations.
  • Review and recommendation of alternate approaches, process hazard analysis (PHA).
  • Failure Modes and Effects Analysis (FMEA), development and delivery of biotechnology training materials, assessment of biosafety principals to ensure compliance with NIH guidelines.
  • Provide review and written recommendations on manufacturing designs and specifications.
  • Evaluations of existing and newly proposed manufacturing infrastructure and equipment.
  • Participate in technical discussions and conduct related research assignments as requested by the customer.
  • Scientific understanding and technical expertise in Biologics and Viral Vector manufacturing.
  • Work product will include technical reports, technical memorandums, presentations, e-mail communications, and other formats to support company-wide communication.
  • Position will involve a combination of on-site and off-site work requirements as needed by the customer.
  • Weekly hours of support will be variable between 0-40 and as needed by customer.
  • Immediate needs will be in the 24-32 hours per week range.

Skills:

  • Process Hazard Analysis (PHA).
  • Failure Modes and Effects Analysis (FMEA).
  • BioSafety Principles and Practices (GLSP, BSL1, BSL2, etc).
  • Risk Assessments Biologics.
  • GMP Manufacturing.
  • Viral Vectors and Gene Therapy.
  • Manufacturing Cell Culture and Purification Processes Design Review.

Education:

  • 10+ years M.Sc. or Ph.D. in biochemistry, molecular biology, biologics or pharmaceutical process engineering.
  • Hours Per Week: 32.00

If you are interested in applying, please send your resumes to: awoods@apexlifesciences.com