Finish (CVRM)

Genentech•Cary, NC

1d•Onsite

About The Position

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. This is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation. We're seeking a highly skilled and experienced Quality Validation Engineer with a focus on Compounding, Filling and Inspection. This role will provide quality oversight of all validation and qualification activities of the Holly Springs high volume facility’s equipment, systems, facilities and utilities. During the plant start-up project you will be on the User Team representing QEV and be accountable for the qualification of all Compounding, Filling, and Inspection systems. 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.

Requirements

For the senior principal level, you have 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.
For the principal level, you have 8+ years of work experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment with equipment, facilities, and utility systems.
You are recognized expert / authority in qualification of Compounding, Filling, and Inspection systems in support of Drug Product manufacturing.
You have broad experience in multiple disciplines of Qualification and Validation including some or all of the following: equipment qualification, cleaning validation, process validation, computer systems, shipping qualification, sanitization/sterilization.
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 direct experience presenting to Regulatory Agencies and supporting technical experts with quality/compliance issues.
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.

Nice To Haves

Experience with both small and large molecule drug products, powder handling, and devices is preferred.

Responsibilities

Drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements.
Provide Quality oversight for the Qualification/Validation of all Compounding, Filling and Inspection equipment and automation systems during the facility start-up project.
Provide strategic guidance to the Validation strategy for PQ and GMP start-up activities of the Compounding, Filling, and Inspection area to ensure an effective filing and commercial launch.
Act as a champion to establish a science and risk based approach to Qualification and Validation.
Understand the bigger picture of the project and the CVRM disease area and how PT contributes to it.
Work closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals.
Effectively partner with and influence stakeholders across the organization without formal authority, and drive technical decisions balancing product, site, and operations views.
Provide leadership for involved project teams and across the broader organisation.
Provide training materials and training for people joining the organisation.
Act as a coach for colleagues with less experience and helps them develop skills/expertise.
Actively build, support, and promote a culture of Continuous Improvement and Quality Mindset within the organisation.