Senior Principal Automation Engineer (CVRM)

Genentech • Holly Springs, NC

13d • Hybrid

About The Position

ITOT supports Pharma Technical Manufacturing (PTM), which manages all aspects of end-to-end drug substance and drug product manufacturing and supply. PTM operates 9 manufacturing sites globally and is constructing a new manufacturing site in Holly Spring, North Carolina, to focus on large volume low cost Drug Product manufacturing. The ITOT/Automation Engineering group will own and operate the Manufacturing Technology stack at the new site. This role is for a Senior Principal Automation Engineer who will participate in Greenfield Project execution and then support the facility post-launch. Initially, the role involves a mix of remote and onsite work, transitioning to full-time onsite work once the buildings are constructed and equipment is delivered. Travel of up to 30% is expected during the project phase. The Senior Principal Automation Engineer will provide automation, instrumentation, and controls engineering capabilities, including generating qualification protocols and maintaining the validated state of systems and processes. The role involves participation in Basic Design, Detailed Design, and Facility Startup, followed by long-term support for automation and control systems for process, utility, and building systems in the new facility. This is a leadership role responsible for leading automation impacting projects of large and/or complex scope, driving strategic initiatives, and acting as both a People Leader/Coach and a hands-on Subject Matter Expert (SME).

Requirements

• 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.
• Knowledge of 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.

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 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.
• Act as the 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).
• Ensure the integration of environmental health, safety, and security into business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.
• Foster a positive safety culture in which no one gets hurt.
• Support the work of the Engineering Group, which includes researching/evaluating instrumentation and control components, and reviewing/modifying control system concept/logic as a result of troubleshooting.

Benefits

• Relocation funding is available for this role.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior