Environmental Monitoring & Equipment Engineer

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

Job summary

Roche Holding AG in California is seeking a Manufacturing Equipment Engineer to safeguard site EMS, manage critical laboratory infrastructure, and drive equipment lifecycle programs. You will lead calibration, maintenance, and NC investigations while coordinating with QA and regulatory teams to ensure data integrity and product quality.

Key responsibilities include EMS administration, NCR/RCA leadership, and supporting FDA/BSI audits.

Qualifications

• Bachelor’s degree in a relevant field.
• 5+ years in utility/equipment engineering in biotech/clinical lab.
• Experience administering continuous environmental monitoring systems (EMS).

Responsibilities

• Serve as EMS system controller and administrator.
• Lead NC investigations and RCA in QMS portals (SAP).
• Support external regulatory audits (FDA/BSI) with equipment records.
• Plan, calibrate, and perform preventive/corrective maintenance.
• Oversee installation, commissioning, and qualification for CTUs and utilities.
• Direct vendor management to control costs and asset life.
• Train site staff on system access and SOPs.

Skills

EMS administration

Regulatory compliance

Lab automation

Vendor management

Root cause analysis

Education

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

Tools

REES

ViewLinc

SAP

Job description

Roche Holding AG in California is seeking a Manufacturing Equipment Engineer to safeguard site EMS, manage critical laboratory infrastructure, and drive equipment lifecycle programs. You will lead calibration, maintenance, and NC investigations while coordinating with QA and regulatory teams to ensure data integrity and product quality.

Key responsibilities include EMS administration, NCR/RCA leadership, and supporting FDA/BSI audits.