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The Position Are you an agile engineering professional looking to keep cutting-edge life sciences laboratories operating at peak performance? Join our cross-functional site network across Santa Clara and Pleasanton as a Manufacturing Equipment Engineer. In this high-impact role, you will safeguard our facility's "Right to Operate" by managing critical laboratory infrastructure, ensuring continuous regulatory compliance, and maximizing system uptime. By serving as the core technical leader for our Environmental Monitoring System (EMS) and quality risk management, your expertise will directly ensure data integrity, operational efficiency, and product quality in a regulated environment.

As a Manufacturing Equipment Engineer, you will serve as the system controller and administrator for the site’s Environmental Monitoring System (EMS), overseeing everything from database administration and alert matrices to software maintenance and sensor allocation. Beyond EMS stewardship, you will drive total equipment lifecycle management across clinical and facility infrastructure—including liquid handling devices, CTUs, and imaging systems—by leading calibrations, preventive maintenance, and troubleshooting. Working closely with quality teams, you will champion Non-Conformance (NC) investigations, execute Root Cause Analysis (RCA) in SAP, and provide front-facing technical support during high-stakes FDA and BSI regulatory audits.

• Serve as the primary system controller for the Environmental Monitoring System (EMS), overseeing database settings, sensor allocations, CTU mapping, alert matrices, and annual software upkeep to ensure 24/7 data integrity.

• Drive end-to-end lifecycle resolution of equipment Non-Conformances (NCs), deviations, and Out-of-Specification (OOS) calibration events, executing robust Root Cause Analysis (RCA) and impact assessments in corporate QMS portals (SAP).

• Provide direct technical front-room and backroom support during internal quality reviews and external regulatory audits (e.g., FDA, BSI) by assembling critical equipment records and excursion logs.

• Plan, validate, calibrate, and perform preventive and corrective maintenance across site equipment and utility systems to minimize operational downtime.

• Oversee the installation, troubleshooting, and C&Q (Commissioning & Qualification) programs for CTUs, process utilities, and facility systems, continuously analyzing system status trends for improvements.

• Direct external vendor management to control costs, guarantee service deliverability, minimize safety risks, and extend asset life across contractual lifecycles.

• Manage system access credentials, conduct technical software training, and act as a qualified trainer for site C&Q Standard Operating Procedures (SOPs).

• Educational Background: Bachelor’s degree in Bioengineering, Automation Engineering, Biology, Biochemistry, or equivalent practical experience.
• Biotech Industry Experience: 5+ years of robust background in utility system and equipment engineering within a biotechnology or clinical laboratory environment.
• Hands-on EMS Administration: Proven track record administering and controlling continuous environmental monitoring system networks (e.g., REES, ViewLinc) including alarm processing and parameter change management.
• Regulatory Compliance & Audits: Direct experience working within cGMP/cGXP or ISO-regulated environments, with a preference for demonstrated support during FDA or BSI inspections.
• Lab Automation & Device Expertise: Practical experience maintaining, deploying, or troubleshooting clinical lab devices, automated liquid handlers, imaging systems, and facility CTUs.

This position is not eligible for relocation. The expected salary range for this position based on the primary location of California is $81,500 - $151,300 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

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