Senior Principal IT/OT Automation Engineer (CVRM) at Genentech

, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jan, 26

Salary

212400.0

Posted On

25 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

IT Infrastructure Engineering, Automation Systems, Cyber Security, Manufacturing Systems, Control Systems, SQL Databases, Project Management, GMP Compliance, Virtualization, Industrial Ethernet Networks, Biopharmaceutical Manufacturing, Data Transfer Protocols, System Qualification, Engineering Drawings, Communication Skills, Troubleshooting, Team Management

Industry

Biotechnology Research

Description

The Position ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity A Senior Principal ITOT Infrastructure Engineer is being hired to participate in Greenfield Project execution and then support the facility after going live. Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. What You'll Do Senior Principal ITOT Infrastructure Engineer (Department: ITOT/Infrastructure - Leadership Role) will be 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. Who You Are 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 Certifications: Certified Information System Security Professional (CISSP), ISA/IEC 62443 Cybersecurity Specialist certification, Global Industrial Cyber Security Professional (GICSP) is a plus Knowledge, Skills and Abilities 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. 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. Relocation funding is available for this role. The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. 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 Genentech 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.

Responsibilities

The Senior Principal ITOT Infrastructure Engineer will provide IT Infrastructure engineering capabilities and support for the ITOT Group, focusing on data center and field IT infrastructure. Responsibilities include leading infrastructure projects, supporting manufacturing systems, and ensuring compliance with cybersecurity initiatives.