Manufacturing Equipment Engineer – EMS & Compliance Lead

Roche; Santa Clara (CA); On-site; USD 82,000 - 151,000; Full time

Job summary

Roche is seeking a Manufacturing Equipment Engineer to protect critical laboratory infrastructure and maintain high regulatory compliance in a fast-paced biotech environment in California. You will lead EMS administration, manage equipment NCs and RCA activities, and support FDA/BSI audits while coordinating maintenance and calibration across site systems.

You will drive lifecycle management for CTUs, liquid handling devices, imaging systems, and facility utilities, collaborating with QA and

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 biotech or clinical lab environments.
• Experience administering continuous environmental monitoring system networks (e.g., REES, ViewLinc).
• Direct experience with cGMP/cGXP or ISO-regulated environments, with FDA/BSI inspections preferred.

Responsibilities

• Serve as the system controller and administrator for the EMS, including database settings, sensor allocations, CTU mapping, and annual software upkeep.
• Drive end-to-end lifecycle resolution of equipment NCs, deviations, and OOS calibration events with RCA in SAP or QMS portals.
• Provide front-room and backroom support during audits by assembling equipment records and excursion logs.
• Plan, validate, calibrate, and perform preventive and corrective maintenance across site equipment and utility systems.
• Oversee installation, commissioning & qualification for CTUs, process utilities, and facility systems; analyze system status trends for improvements.
• Direct external vendor management to control costs, ensure service deliverability, and extend asset life.

Skills

EMS Administration

Regulatory Compliance

Lab Automation

Audits

Vendor Management

Education

Bachelor’s degree in Bioengineering/Automation Engineering/Biology/Biochemistry

Tools

REES

ViewLinc

SAP

Job description

Roche is seeking a Manufacturing Equipment Engineer to protect critical laboratory infrastructure and maintain high regulatory compliance in a fast-paced biotech environment in California. You will lead EMS administration, manage equipment NCs and RCA activities, and support FDA/BSI audits while coordinating maintenance and calibration across site systems.

You will drive lifecycle management for CTUs, liquid handling devices, imaging systems, and facility utilities, collaborating with QA and