Roche · 2 months ago
Senior Principal Automation Engineer (CVRM)
California
Full-time
Hybrid
Senior Level, Lead/Staff
$114K/yr - $212K/yr
7+ years expRoche is a leading global healthcare company that focuses on delivering innovative therapies. They are seeking a Senior Principal Automation Engineer to participate in the execution of a Greenfield Project and provide long-term support for newly built facilities, focusing on automation and control systems for manufacturing processes.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
Provide automation, instrumentation, and control engineering design services for facility projects, including upgrades, capacity expansions, and equipment replacements
Produce and review design drawings and specification documents (URS, FS, DS, etc.)
Support end-to-end system qualification, including test creation, execution, review and approval
Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget
Review and approve vendor information packages, including drawings and specifications as directed to ensure user requirements are met
Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings
Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes
Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans)
Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines
Automation lead for equipment/software FAT, field testing and commissioning
Provide scope, qualification, resource, and budget estimates for automation impacting projects
Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team
Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices
Provide input into network/global business processes and procedures (e.g. GSPs)
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt
Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting
Qualification
Required
Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 7 years experience
Minimum of 8 years applicable automation and/or instrument and control system experience preferably majority in drug product function
5 years in the pharmaceutical/biotech industry/GMP experience
24X7 on call support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required
Experience with Biopharmaceutical manufacturing, design or/and construction
Knowledge of Industrial Ethernet networks for manufacturing
Knowledge of vision systems
Knowledge of Drug Product Manufacturing processes including aseptic or robotic fillings systems, vial handling, environmental monitoring and clean utilities
Knowledge of communication protocols for devices (OPC, Modbus, MQTT, Ethernet IO, IOT)
Knowledge of integration and data transfer with Level 2, 3, and 4 systems
Qualification experience related to control and computer systems
Ability to generate engineering drawings and specifications
Knowledge of ISA standards and practices for instrumentation
Knowledge of PID control theories and techniques
Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred)
Practical knowledge of process automation systems, and associated programming languages (Rockwell and Siemens preferred)
Demonstrate strong organizational, communication, and interpersonal skills to effectively manage tasks and collaborate with diverse teams
Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility
Demonstrate strong working knowledge of PC based programs and web based systems
Ability to work independently with no direct supervision
Knowledge of GAMP5
Work in a standard office environment
May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment
May work with hazardous materials and chemicals
Benefits
Relocation funding is available for this role.
A discretionary annual bonus may be available based on individual and Company performance.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase