Genentech
Senior Principal IT/OT Automation Engineer (CVRM)
Genentech, Los Angeles, California, United States, 90079
Join to apply for the
Senior Principal IT/OT Infrastructure Engineer (CVRM)
role at
Genentech .
Position Overview ITOT supports Pharma Technical Manufacturing (PTM), which manages all aspects of end‑to‑end drug substance and drug product manufacturing and supply. For the new site in Holly Springs, North Carolina, ITOT will own and operate the Manufacturing Technology stack, working with Global IT.
Opportunity A Senior Principal ITOT Infrastructure Engineer will drive Greenfield Project execution and subsequently support the facility after go‑live. Initially, the role involves a mix of remote and onsite work, transitioning to full‑time on‑site at the plant. Travel up to 30% of the time is expected during the project phase.
What You’ll Do
Act as the site owner of “OT Infrastructure” for Manufacturing System Platforms (Syncade MES, DeltaV, PLCs, Lab Data Systems).
Lead Global Cyber Security initiatives and be the OT Infrastructure support lead for global infrastructure solutions.
Collaborate with IT Engineers, Architects, and Automation Engineers.
Lead and/or support the installation, configuration, and maintenance of control systems hardware, software, networks, and security.
Execute control system virtualization, user administration, system monitoring, and capacity planning.
Perform end‑to‑end system qualification, including test creation, execution, review, and approval.
Write and review specification documents (URS, FS, DS).
Provide expertise bridging Automation and underlying Storage, Compute, and Network infrastructure.
Lead project management activities: design, qualification, resource, budget, status updates, and contractor management.
Support plant operations, troubleshooting, and automation design and qualification deliverables.
Adhere to GAMP5, cGMP, and company SOPs.
Who You Are
Bachelor’s degree in Engineering, Computer Science, or equivalent experience.
Minimum 5 years of systems engineering experience in automation design, implementation, or support, preferably in a regulated pharmaceutical industry.
Experience with 24/7 support and on‑call availability.
Hands‑on experience with Operating Systems, Virtualization, LAN/WAN, Firewalls, SQL Servers, and system administration.
Certifications such as CISSP, ISA/IEC 62443 Cybersecurity Specialist, or GICSP are a plus.
Knowledge, Skills & Abilities
Biopharmaceutical manufacturing design or construction experience.
Knowledge of Industrial Ethernet networks, vision systems, and communication protocols (OPC, Modbus, MQTT, Ethernet IO, IOT).
Understanding of Drug Product Manufacturing processes (aseptic or robotic fillings, vial handling, environmental monitoring).
Experience with control and computer systems qualification.
Strong organizational, communication, and interpersonal skills.
Ability to work independently with minimal supervision.
Knowledge of GAMP5 and working in a clean‑room environment (gowning, hazardous materials handling).
Relocation Funding Relocation funding is available for this role.
Salary Expected salary range for the position at Holly Springs, North Carolina is $114,400 – $212,400.
Benefits Genentech is an equal‑opportunity employer. We prohibit unlawful discrimination and comply with all applicable laws. If you have a disability and need an accommodation in the online application process, please contact us by completing the
Accommodations for Applicants
form.
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Senior Principal IT/OT Infrastructure Engineer (CVRM)
role at
Genentech .
Position Overview ITOT supports Pharma Technical Manufacturing (PTM), which manages all aspects of end‑to‑end drug substance and drug product manufacturing and supply. For the new site in Holly Springs, North Carolina, ITOT will own and operate the Manufacturing Technology stack, working with Global IT.
Opportunity A Senior Principal ITOT Infrastructure Engineer will drive Greenfield Project execution and subsequently support the facility after go‑live. Initially, the role involves a mix of remote and onsite work, transitioning to full‑time on‑site at the plant. Travel up to 30% of the time is expected during the project phase.
What You’ll Do
Act as the site owner of “OT Infrastructure” for Manufacturing System Platforms (Syncade MES, DeltaV, PLCs, Lab Data Systems).
Lead Global Cyber Security initiatives and be the OT Infrastructure support lead for global infrastructure solutions.
Collaborate with IT Engineers, Architects, and Automation Engineers.
Lead and/or support the installation, configuration, and maintenance of control systems hardware, software, networks, and security.
Execute control system virtualization, user administration, system monitoring, and capacity planning.
Perform end‑to‑end system qualification, including test creation, execution, review, and approval.
Write and review specification documents (URS, FS, DS).
Provide expertise bridging Automation and underlying Storage, Compute, and Network infrastructure.
Lead project management activities: design, qualification, resource, budget, status updates, and contractor management.
Support plant operations, troubleshooting, and automation design and qualification deliverables.
Adhere to GAMP5, cGMP, and company SOPs.
Who You Are
Bachelor’s degree in Engineering, Computer Science, or equivalent experience.
Minimum 5 years of systems engineering experience in automation design, implementation, or support, preferably in a regulated pharmaceutical industry.
Experience with 24/7 support and on‑call availability.
Hands‑on experience with Operating Systems, Virtualization, LAN/WAN, Firewalls, SQL Servers, and system administration.
Certifications such as CISSP, ISA/IEC 62443 Cybersecurity Specialist, or GICSP are a plus.
Knowledge, Skills & Abilities
Biopharmaceutical manufacturing design or construction experience.
Knowledge of Industrial Ethernet networks, vision systems, and communication protocols (OPC, Modbus, MQTT, Ethernet IO, IOT).
Understanding of Drug Product Manufacturing processes (aseptic or robotic fillings, vial handling, environmental monitoring).
Experience with control and computer systems qualification.
Strong organizational, communication, and interpersonal skills.
Ability to work independently with minimal supervision.
Knowledge of GAMP5 and working in a clean‑room environment (gowning, hazardous materials handling).
Relocation Funding Relocation funding is available for this role.
Salary Expected salary range for the position at Holly Springs, North Carolina is $114,400 – $212,400.
Benefits Genentech is an equal‑opportunity employer. We prohibit unlawful discrimination and comply with all applicable laws. If you have a disability and need an accommodation in the online application process, please contact us by completing the
Accommodations for Applicants
form.
#J-18808-Ljbffr