🚀 Senior Principal Automation Engineer (CVRM)

Senior Principal Automation Engineer (CVRM)

Join Genentech to help construct a new manufacturing site in Holly Springs, North Carolina, focusing on large volume drug product manufacturing.

Overview

As a Senior Principal Automation Engineer, you will participate in green‑field project execution and provide ongoing support post‑commissioning. You will work on a mix of remote and onsite tasks, traveling as needed (up to 30% of the time) during the project phase before transitioning to full‑time onsite work once construction and equipment delivery are complete.

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 provide real‑time floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.
• Author and adhere to site SOPs and work instructions for daily and project deliverables, driving improvements to business processes.
• Support inspection activities to present automation design and qualification deliverables and strategy (e.g., Qualification Project Plans and Master Plans).
• Automate 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 timesheets and invoices.
• Provide input into network/global business processes and procedures (e.g., GSPs).
• Ensure integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents.
• Support work of the Engineering Group, which includes researching/evaluating instrumentation and control components, reviewing/ modifying control system concepts/ logic as a result of troubleshooting.

Qualifications

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience, or Master’s degree and 7 years experience.
• Minimum of 8 years applicable automation and/or instrument/ control system experience, preferably majority in drug product function.
• 5 years in the pharmaceutical/biotech industry/GMP experience.
• 24×7 on‑call support, participate in an on‑call environment to meet business continuity requirements, including weekends and holidays as required.

Knowledge, Skills & Abilities

• Experience with biopharmaceutical manufacturing, design or construction.
• Knowledge of industrial Ethernet networks for manufacturing.
• Knowledge of vision systems.
• Knowledge of drug product manufacturing processes, including aseptic or robotic filling 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 requiring gowning in hospital scrubs, coveralls, gloves, and steel‑toe boots. No makeup or jewelry may be worn.
• May work with hazardous materials and chemicals.

Relocation Funding

Relocation funding is available for this role.

Benefits and Compensation

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.

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.