Black Utilities Manager, CVRM (Holly Springs)

Genentech•Holly Springs, NC

2d•Onsite

About The Position

Pharma Technical Manufacturing (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 Springs, North Carolina. 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 We're seeking a highly skilled and experienced Black Utilities Manager who will be accountable for the technical and operational oversight for the Holly Springs site utility equipment and infrastructure on the 102 acre site. Utility equipment includes water (refrigerated, tower, heating hot, domestic), high-pressure compressed air, building HVAC, generator support and power distribution systems, fire life safety system, and sewer. The Manager will provide oversight & development of utility operations, preventive maintenance of the equipment and utilities, development of service contracts, approve maintenance strategies and manage the vendors work quality and completion. What You'll Do Pre-Startup: During the plant start-up project you will be on the User Team for Black Utility systems and be accountable for implementing all global asset management processes and ensuring appropriate criticality, FMEA, and preventive maintenance programs are in place. In partnership with the Engineering and the start-up project (user) team you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility. 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. Post-Startup: You will provide strategic and tactical leadership to ensure that the utilities serving the site operate with maximum reliability through its total equipment lifecycle. You will drive optimal black utility performance to enable high manufacturing efficiency. This includes inputs to the creation of master data in SAP S4/HANA our Computerized Calibration / Maintenance Management Software. You will champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management. This also includes provision and realization of creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects. Presents ideas, project goals, progress, risks, and results across departments and to senior management. You will oversee the continuous, reliable operation of black utilities supporting the site. This includes partnering with the suppliers and contracts to build all required processes, master data, documents, and tests to transition the design plans into a functioning, approved manufacturing site and organization. You understand the bigger picture of the project and the CVRM disease area and how PT contributes to it. Works closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals. Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views. You will provide leadership for involved project teams and across the broader organization. Provides training materials and training for people joining the organisation. Acts as a coach for colleagues with less experience and helps them develop skills/expertise. You will ensure the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents within one’s functional area. Fosters a safe and compliant speak up culture. Actively build, support, and promote a culture of continuous improvement and learning from both successes and failures.

Requirements

You have a Bachelor’s degree in Engineering or a related field.
You have 5+ years of work experience in a manufacturing industry with direct experience operating, maintaining, and/or managing black utilities.
You have 2+ years of people leadership experience.
You are recognized expert / authority in Black Utility Systems in support of manufacturing including but not limited to water systems, HVAC, waste, and electrical systems..
You have an ability to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
You have experience with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters.
Utilizes an established network for technical issues within the company and the industry.
You have strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources.
Is able to coach others.

Responsibilities

During the plant start-up project you will be on the User Team for Black Utility systems and be accountable for implementing all global asset management processes and ensuring appropriate criticality, FMEA, and preventive maintenance programs are in place.
In partnership with the Engineering and the start-up project (user) team you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility.
You will provide strategic and tactical leadership to ensure that the utilities serving the site operate with maximum reliability through its total equipment lifecycle.
You will drive optimal black utility performance to enable high manufacturing efficiency.
Presents ideas, project goals, progress, risks, and results across departments and to senior management.
You will oversee the continuous, reliable operation of black utilities supporting the site.
Works closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals.
Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views.
You will provide leadership for involved project teams and across the broader organization.
Provides training materials and training for people joining the organisation.
Acts as a coach for colleagues with less experience and helps them develop skills/expertise.
You will ensure the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents within one’s functional area.
Fosters a safe and compliant speak up culture.
Actively build, support, and promote a culture of continuous improvement and learning from both successes and failures.