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.
Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, 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.
Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.
The Opportunity
We're seeking a highly skilled and experienced Quality Validation Engineer with a focus on Assembly and Packaging. 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 Assembly and Packaging equipment and supporting systems. You will partner and collaborate with our partner organizations (Engineering, 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.
What You'll Do
You will 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 Assembly and Packaging equipment and automation systems during the facility start-up project.
You will provide strategic guidance to the Validation strategy for PQ and GMP start-up activities of the Assembly and Packaging area to ensure an effective filing and commercial launch.
You will act as a champion to establish a science and risk based approach to Qualification and Validation.
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.
Actively build, support, and promote a culture of Continuous Improvement and Quality Mindset within the organisation.
Who You Are:
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 assembly and packaging equipment.
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 assembly and packaging equipment.
You are recognized expert / authority in qualification of automated production equipment in support of Drug Product manufacturing including but not limited to assembly and packaging systems.
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, and devices
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.
The expected salary range for this position at the Senior Principal level is $113,100 - $210,100. The expected salary range for this position at the Principal level is $93,000 - $172,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.