Process Engineer

SILVER LAKE RESEARCH is a global industry leader in MAb and LFA development.  The Company‚Äôs test kits are single-use, inexpensive, one-step immunoassays similar to home pregnancy tests, providing non-technical users with lab-accurate diagnostic results on the spot.  Our products are sold on six continents and are being deployed by governmental organizations and NGOs for public health screening, veterinary disease surveillance, and food and environmental contaminant detection.  Our outstanding track record of success in contract development projects makes us a trusted resource for government and private industry partners.

 

SLRC currently has an exciting opportunity for an experienced Process Engineer to work in our Azusa, CA facility.  This is an R&D position in the Diagnostics Development Department, centering on providing process engineering solutions for multiple test kits currently being developed by the Company. This is a full-time, onsite position.

 

Responsibilities include:

  • Providing process control and design control expertise for the development and production of diagnostic products. 
  • Leading ISO/FDA regulated product development activities.
  • Leading process scale-up and technology transfer activities working within cGMP, GLP and ISO compliance.
  • Managing new product development teams, developing project timelines, and providing project schedule reports.

 

Required Skills:

  • 5+ years product or process engineering experience in a diagnostics / medical device company.
  • Experience with immunoassay diagnostics is preferred.
  • Expertise working within cGMP, ISO and GLP compliance and providing GMP, ISO and GLP documentation.
  • Expertise leading scale-up, technology transfer and process validation activities
  • Expertise leading project teams and managing project timelines.
  • Excellent verbal and written communication skills.