Utilities Plant Engineering Lead, CVRM (Holly Springs)

Genentech•Holly Springs, NC

41d•$114,400 - $256,800•Hybrid

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 Spring, 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). We're seeking a highly skilled and experienced Utilities Plant Engineering Lead who will be accountable for end to end asset/system management including plan, design, build and test, maintain and decommission. This includes ensuring the continuous, reliable, compliant, and efficient operation of all utilities to support cGMP manufacturing activities. During the plant start-up project you will be on the User Team for 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, qualification, validation, 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. You will drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements. 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, to senior management, and at international meetings. You will oversee the continuous, reliable operation of critical utilities supporting manufacturing. 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 facility and organisation. It will also require ownership of the Quality Management System (QMS) aspects related to Utilities, including deviations, CAPAs, and change controls and timely in-the-field troubleshooting for all Utility systems. 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 organisation. 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. You will design and execute studies and comparability protocols to support the required operations. You will contribute to cGMP documentation and regulatory filings.

Requirements

Bachelor's degree in Engineering (preferred)
12+ years of work experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment with equipment, facilities, and utility systems.
Recognized expert / authority in Utility Systems in support of Drug Product manufacturing including but not limited to WFI, clean steam, process gases, HVAC/R, waste neutralization, refrigerated water, and bulk chemicals.
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.
Updated knowledge of cGMP's, Health Authority regulations, and Quality Systems.
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.
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

Accountable for end to end asset/system management including plan, design, build and test, maintain and decommission.
Ensuring the continuous, reliable, compliant, and efficient operation of all utilities to support cGMP manufacturing activities.
Implementing all global asset management processes and ensuring appropriate criticality, FMEA, and preventive maintenance programs are in place.
Partnering and collaborating with partner organizations to provide expertise in project management and technical design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility.
Driving optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements.
Overseeing the continuous, reliable operation of critical utilities supporting manufacturing.
Building all required processes, master data, documents, and tests to transition the design plans into a functioning, approved manufacturing facility and organisation.
Ownership of the Quality Management System (QMS) aspects related to Utilities, including deviations, CAPAs, and change controls and timely in-the-field troubleshooting for all Utility systems.
Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views.
Provide leadership for involved project teams and across the broader organisation.
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.
Design and execute studies and comparability protocols to support the required operations.
Contribute to cGMP documentation and regulatory filings.