Facilities Engineering Lead, CVRM (Holly Springs)

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). 

The Opportunity: 

We're seeking a highly experienced and strategic Facilities Engineering Lead to oversee all facilities-related operations at our state-of-the-art manufacturing site. This critical role ensures the continuous, compliant, and efficient operation of all plant infrastructure, utilities, and services to support cGMP manufacturing activities.

During the plant start-up project you will act as User Team Lead for Facilities owned 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. 

As part of plant start-up you will act as the Facilities ASSET main functional contact (MFC) for the SAP ERP deployment; responsible for the timeline, deliverables, and adherence to the global template processes. 

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 develop and execute a comprehensive Facilities Management strategy aligned with the site's manufacturing goals, regulatory requirements, and capital improvement plans.  This includes ensuring all facility operations, documentation, programs (e.g. Calibration and Preventative Maintenance) and infrastructure (e.g., HVAC, cleanrooms, utilities, water systems, electrical systems) are maintained in a validated and compliant state according to cGMP, FDA, EMA, and local regulations.

• 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 success