Manufacturing Equipment Engineer
$81,500–$151,300 year
On-siteSanta Clara, California, United States or Pleasanton, California, United States
Job Summary
Manage the site's Environmental Monitoring System (EMS) as the primary controller, overseeing database settings, sensor allocations, and software maintenance to ensure 24/7 data integrity. Lead end-to-end equipment lifecycle management by planning calibrations, preventive maintenance, and troubleshooting for liquid handling devices, CTUs, and imaging systems. Drive Root Cause Analysis for Non-Conformances and Out-of-Specification events within corporate QMS portals while providing technical support during FDA and BSI regulatory audits. Oversee vendor contracts, manage system access credentials, and train staff on Commissioning & Qualification Standard Operating Procedures to minimize operational downtime.
Required Qualifications
- Bachelor's degree in Bioengineering, Automation Engineering, Biology, Biochemistry, or equivalent practical experience
- 5+ years of robust background in utility system and equipment engineering within a biotechnology or clinical laboratory environment
- Proven track record administering and controlling continuous environmental monitoring system networks (e.g., REES, ViewLinc) including alarm processing and parameter change management
- Direct experience working within cGMP/cGXP or ISO-regulated environments
- Practical experience maintaining, deploying, or troubleshooting clinical lab devices, automated liquid handlers, imaging systems, and facility CTUs
- This position is not eligible for relocation
Desired Qualifications
- demonstrated support during FDA or BSI inspections
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.