EMS & Equipment Reliability Engineer (Manufacturing)

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

Job summary

Roche in California seeks a Manufacturing Equipment Engineer to manage the Environmental Monitoring System (EMS) and oversee equipment lifecycle across clinical and facility infrastructure. You will ensure regulatory compliance, drive maintenance programs, and support audits in a fast-paced biotech setting.

Ideal candidates bring 5+ years in biotech utility engineering, hands-on EMS experience, and a track record in NC investigations and RCA within GMP environments.

Qualifications

• Bachelor's degree in Bioengineering or related field.
• 5+ years in biotech utility/equipment engineering.
• Experience with EMS and regulatory environments.

Responsibilities

• Manage EMS database, sensors, and maintenance to ensure data integrity.
• Lead NC investigations and RCA using SAP.
• Support FDA/BSI audits with equipment records and logs.
• Plan maintenance across site equipment to minimize downtime.
• Oversee installation, commissioning, and qualification of CTUs and utilities.
• Direct vendor management to control costs and service quality.
• Provide site training on SOPs and system access.

Skills

EMS Administration

Regulatory Compliance

Lab Automation

Device Expertise

Education

Bachelor’s degree in Bioengineering, Automation Engineering, Biology, Biochemistry, or equivalent practical experience

Tools

REES

ViewLinc

SAP

Job description

Roche in California seeks a Manufacturing Equipment Engineer to manage the Environmental Monitoring System (EMS) and oversee equipment lifecycle across clinical and facility infrastructure. You will ensure regulatory compliance, drive maintenance programs, and support audits in a fast-paced biotech setting.

Ideal candidates bring 5+ years in biotech utility engineering, hands-on EMS experience, and a track record in NC investigations and RCA within GMP environments.