Principal Instrumentation & Controls Plant Engineer - CVRM (Holly Springs)

Genentech

3d•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 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 along with associated Utilities and Warehouse). We're seeking a highly skilled and experienced Principal Instrumentation & Controls Plant Engineer who will be the site’s highest-level technical subject matter expert (SM) for the site’s instrumentation program. Pre-Startup: During the plant start-up project you will be on the User Team and be accountable for establishing the site’s foundational calibration strategy and program. In partnership with Project Engineering and the start-up project (user) team you will partner and collaborate with our partner site 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 with a focused lens on instrumentation. 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 facility's measurement and control hardware operates with maximum reliability and in strict compliance with cGMP standards.

Requirements

You have a bachelor's degree and 5+ years of work experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment with Instrumentation.
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 updated knowledge of cGMP’s, Health Authority regulations, and Quality Systems.
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. Coaches others.
Ability to work in an international/global environment.
Domestic and international travel required.
Travel up to 20% post-startup.
May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and safety boots.
Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.
Demonstrated expertise / experience working safely on or near electrical equipment.

Responsibilities

Drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements. This includes inputs to the creation of calibration master data in SAP S4/HANA our Computerized Calibration Management Software.
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.
Serve as backline technical support and troubleshooting for the site’s instrumentation. This includes in the field troubleshooting, root cause analysis, and deviation, change control, and CAPA ownership. This will require strong collaboration with Automation, Validation, Calibration, Quality, and Manufacturing.
Develop and optimize a reliability program for Instrumentation and proactively manage instrumentation obsolescence.
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.
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.