Senior Project Engineer Process Automation

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 99,820 - 185,380; Full time

Job summary

Genentech, a member of the Roche family, is seeking a Senior Project Engineer for Process Automation Systems to deliver advanced automation across pharmaceutical manufacturing, packaging, and warehouse operations. The role owns the full lifecycle, ensuring GMP/compliance and successful execution in digital manufacturing initiatives.

The candidate will lead design, qualification, and commissioning of DCS, PLC/SCADA, MES, and data historians, and collaborate across teams while traveling for

Qualifications

• Bachelor's degree in automation-related field; Master’s preferred.
• 5+ years in pharmaceutical/biotech automation projects.
• Experience with regulatory compliance (FDA/EMA) and GMP.

Responsibilities

• Lead planning, design, procurement, and qualification of automation systems.
• Define architectures and conduct feasibility studies per Roche standards.
• Manage integration with process equipment, packaging, and warehouse systems.
• Interface with suppliers and project teams to ensure performance.
• Lead CSV/qualification activities and commissioning under GMP and cybersecurity standards.

Education

Bachelor's degree in Automation Engineering or Mechatronics

Tools

DCS

PLC/SCADA

MES

Data Historian

Job description

Role Overview

This Senior Project Engineer for Process Automation Systems will serve as a subject‑matter expert responsible for delivering advanced automation solutions for manufacturing, packaging, and warehouse operations across pharmaceutical and biotech environments.

The role entails ownership of the entire project lifecycle, ensuring compliance, performance, and successful execution while driving progress in digital manufacturing and Industry4.0 initiatives.

Key Responsibilities

• Lead the planning, design, specification, procurement, implementation, and qualification of process automation systems, including DCS, PLC/SCADA, MES, and data historian platforms.
• Define global automation architectures and system concepts, conducting feasibility studies and aligning solutions with Roche engineering standards.
• Manage automation system integration with process equipment, utility systems, robotics, packaging & inspection systems, and warehouse automation.
• Act as the technical and commercial interface to suppliers, integrators, engineering firms, and procurement teams, driving supplier innovation and performance.
• Collaborate with multidisciplinary teams to align automation scope with project priorities and stakeholder expectations, providing regular progress updates and risk mitigation strategies.
• Lead Computer System Validation (CSV), qualification activities, and commissioning efforts in compliance with GMP, FDA, EMA, and cybersecurity standards.
• Support digital transformation initiatives through advanced process control, batch analytics, smart manufacturing, and IT/OT convergence solutions.

Qualifications

• Bachelor’s degree in Automation Engineering, Mechatronics, or a related discipline (Master’s degree is a plus).
• 5+ years of experience, preferably in the pharmaceutical or biotech industry.
• Strong background in automation architecture design, project execution, commissioning and validation.
• Demonstrated ability to execute complex scope on mid‑sized to large‑scale projects.
• Experience with regulatory compliance (FDA, EMA) and GMP requirements for synthetic molecule manufacturing operations.
• Project delivery experience in pharmaceutical manufacturing environments.
• Significant travel (50% or more) with assignment required to meet business needs, including on‑site presence during FAT/SAT activities and international project assignments of 1 to 3 years.

Salary range based on the primary location of Oceanside: $99,820–$185,380. Compensation will be determined by experience, qualifications, geographic location, and other factors permitted by law. A discretionary annual bonus may be available.

Benefits are available in accordance with company policy. This is an on‑site position; no remote options are available at this time. Relocation benefits are not approved for this posting.

Genentech is an equal opportunity employer and prohibits unlawful discrimination. The company’s policy ensures a merit‑based employment process in compliance with federal, state, and local laws. Applicants requiring accommodations in the application process may contact the Accommodations for Applicants form.