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Control Systems Lead (Automation Manager - Holly Springs)

Welcome to Holly Springs, North Carolina- home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.

The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

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).

Control Systems Lead 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.

The Opportunity

Control Systems Lead/ Automation Manager (Department: ITOT/Automation Engineering - Leadership Role) will be Responsible for providing automation ad 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.

Key Responsibilities

• Manage and lead the site automation engineering team, overseeing professional development and daily operations.

• Drive the automation strategy for the facility, ensuring alignment with global standards and local manufacturing needs.

• Oversee the design, commissioning, and validation of process control systems for the Greenfield project.

• Establish and maintain robust life cycle management for all site control and manufacturing systems.

• Partner with IT and Quality stakeholders to ensure data integrity and compliance across all automated platforms.

Who You Are

• Bachelor's degree in Engineering, Computer Science, IT or related engineering or scientific discipline.

• A minimum of 10 years systems engineer experience involved in the design, implementation, and/or support of Rockwell control systems, preferably in a regulated industry. At least 3 years experience managing teams.

• 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required.

• Experience Administering Control Systems such as Rockwell SCADA (System Administrator).

• Experience with control system hardware e.g., controller, power supplies, and I/O's.

• Experience with Rockwell SCADA,Pharmasuite, OSIsoft PI, Rockwell and other PLC's,AssetCentre, Studio 5000 Logix, and various OPC architectures is a plus.

• Experience working with Antivirus and backup applications for Control Systems.

The successful candidate will be:

• Overall Site Systems Lead, People Leader Accountable for all site control systems).

• Supporting ITOT Operating Model evolution become Regional Control Systems Owner/ Lead formultiple sites in North America Region.

• Expected to be hands on Technical Manager with significant seniority and presence.

• Site Owner / Technical System Owner and administrator of "Distributed Control Systems"primarily focusing on DeltaV Distributed Control System, may include other site control systems.

• Site control systems (primarily Rockwell SCADA) Support Lead for systems scope.

• Driver for reliability and continuous improvement for Control Systems.

• Member of the Site ITOT Run Squad and Site ITOT Leadership Team.

Qualifications and Competencies

• Extensive leadership experience in biopharmaceutical automation, with a focus on team management and strategic planning.

• Advanced proficiency in Rockwell SCADA, and MES architectures within a GxP environment.

• Strong understanding of GAMP5 and computer system validation (CSV) requirements.

• Demonstrated ability to manage complex cross-functional projects and external vendors.

The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $130,600 - $242,600. 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.

Benefits

Relocation benefits are not available for this job posting.

#CVRM

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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