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Holly Springs, North Carolina, United States
Hybrid
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 Automation 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.
Senior Principal Automation Engineer (Department: ITOT/Automation Engineering - Leadership Role) will be responsible for providing automation and instrumentation and controls engineering capabilities and experience to the ITOT / Automation Engineering Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup. Eventually focuses on providing long-term support for newly built facilities with respect to the automation and instrumentation and control systems for process, utility and building systems. Lead automation 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.
What You'll Do
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.
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 Engineering 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 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 7years 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, 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.
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.
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.
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.
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