Senior Principal Automation Engineer (CVRM)

Genentech • Cary, NC

21d • $114,400 - $212,400 • Hybrid

About The Position

The ITOT department supports Pharma Technical Manufacturing (PTM), which manages end-to-end drug substance and drug product manufacturing and supply. PTM ensures the delivery of Roche’s therapies to patients worldwide, operating nine manufacturing sites globally. To meet the increasing demand for Cardiovascular, Renal and Metabolism (CVRM) therapies, PTM is establishing a new manufacturing site in Holly Springs, North Carolina. This site will focus on large-volume, low-cost Drug Product manufacturing, encompassing Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, and Packaging/Finished Products. ITOT will be responsible for the site's Manufacturing Technology stack, collaborating with Global IT. A Senior Principal Automation Engineer is sought to contribute to the Greenfield Project execution and subsequently support the facility post-launch. Initially, the role will involve a blend of remote and onsite work, transitioning to full-time on-site presence once the facility is operational. Travel up to 30% is anticipated during the project phase.

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.
• 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.
• 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

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 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.
• Act as 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 the 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 work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.

Benefits

• Relocation funding is available for this role.
• Discretionary annual bonus may be available based on individual and Company performance.
• Benefits detailed at the link provided below.

What This Job Offers

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