Manufacturing Equipment Engineer

Roche•Pleasanton, CA

5d•Hybrid

About The Position

At Roche, we foster a culture where you can be yourself and are embraced for your unique qualities. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted, and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop, and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. 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.

Requirements

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, with a preference for demonstrated support during FDA or BSI inspections.
Practical experience maintaining, deploying, or troubleshooting clinical lab devices, automated liquid handlers, imaging systems, and facility CTUs.

Responsibilities

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).