Manufacturing Equipment Engineer

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. 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.

The Opportunity

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.

• EMS Administration & Control: 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
• Non-Conformance & RCA Leadership: Drive end-to‑end lifecycle resolution of equipment Non‑Conformances (NCs), deviations, and Out-of-Speculation (OOS) calibration events, executing robust Root Cause Analysis (RCA) and impact assessments in corporate QMS portals (SAP)
• Audit & Compliance Support: 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
• Equipment Lifecycle & Maintenance: Plan, validate, calibrate, and perform preventive and corrective maintenance across site equipment and utility systems to minimize operational downtime
• Infrastructure & Commissioning Support: Oversee the installation, troubleshooting, and C&Q (Commissioning & Qualification) programs for CTUs, process utilities, and facility systems, continuously analyzing system status trends for improvements
• Vendor & Budget Oversight: Direct external vendor management to control costs, guarantee service deliverability, minimize safety risks, and extend asset life across contractual lifecycles
• Site Training & Administration: Manage system access credentials, conduct technical software training, and act as a qualified trainer for site C&Q Standard Operating Procedures (SOPs)

Who You Are

• 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.

Benefits

Who we are

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life‑changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.