Genentech · 2 months ago
Senior Principal IT/OT Automation Engineer (CVRM)
Holly Springs, NC
Full-time
Onsite
Senior Level, Lead/Staff
$114K/yr - $212K/yr
5+ years expGenentech is a leading biotechnology company focused on delivering innovative therapies. They are seeking a Senior Principal IT/OT Automation Engineer to provide IT infrastructure engineering capabilities for their new manufacturing site, ensuring readiness for large volume drug product manufacturing and supporting facility operations post-launch.
BiotechnologyLife ScienceManufacturing
Responsibilities
Responsible for providing IT Infrastructure engineering capabilities and experience to the ITOT Group including generating qualification protocols and maintaining the validated state of systems and processes
Initially, participates in Basic Design, Detailed Design and Facility Startup focussed on data center and filed IT infrastructure
Eventually focuses on providing long-term support for newly built facilities with respect to the Infrastructure for process, utility and building systems
Lead Infrastructure impacting projects with large and/or complex scope
Drive strategic initiatives to improve business processes
Be both a People Leader/ Coach and at times hands on SME
Act as Cyber Security Coordinator / Engineer
Provide basic IT support for Site workplace needs in collaboration with Global IT groups
Site Owner of 'OT Infrastructure' for Manufacturing System Platforms including Syncade MES, DeltaV Distributed Control System, PLC's, Lab Data Systems (Smartline Data Cockpit)
Site Lead for Global Cyber Security Initiatives
Site OT Infrastructure Support Lead and Coordinator with Global Infrastructure solutions at site (e.g. support of AD and firewall policies to allow proper access and communication from either AD security or network firewall policies, and commissioning and startup support)
May eventually expand role to become Regional OT Infrastructure Lead for multiple sites supporting ITOT operating model evolution
Collaborate with IT Engineers and Architects, Automation Engineers
Lead and/or provide support for the evaluation, installation, and maintenance of Manufacturing infrastructure including installation and upgrade of control systems hardware, software, control networks, user administration, database administration, security, system monitoring, backup and recovery of Microsoft Windows Server Operating Systems and SQL Databases
Lead and/or support implementation of OT infrastructure standards and best practices across all Site OT and Process Automation platforms, working with other process automation engineers, IT and OT professionals
Support commissioning and startup activity of new process control systems and manufacturing systems (Syncade, DeltaV, PLC’s, OSI PI historian, etc)
Be the go to Infrastructure expert at the site who bridges the gap between Automation and underlying Storage Compute and Network infrastructure
Execute control system virtualization administration, user administration, system monitoring, capacity planning, design, installation, configuration, and upgrade of platform
Execute computer system validation and control system lifecycle management
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 Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting
Qualification
Required
Bachelor's degree in Engineering, Computer Science, or equivalent experience
A minimum of 5 years systems engineer experience involved in the design, implementation, and/or support of automation systems, preferably in a regulated (Pharmaceutical) industry
24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required
Experience with Operating Systems, Virtualization, LAN/WAN, Firewalls, SQL Servers client-server and terminal virtualization as a System Administrator
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
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
Preferred
Certifications: Certified Information System Security Professional (CISSP), ISA/IEC 62443 Cybersecurity Specialist certification, Global Industrial Cyber Security Professional (GICSP) is a plus
Experience with Biopharmaceutical manufacturing, design or/and construction
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Relocation funding is available for this role.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech 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 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President
Recent News
2026-01-07
MarketScreener
2026-01-06
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