Principal/Senior Principal Quality Engineer, Validation - Compounding/Fill/Finish (CVRM)

Roche • South San Francisco, CA

1d • Onsite

About The Position

Welcome to Holly Springs, North Carolina, home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up facility. This state-of-the-art plant will leverage next-generation technology, high-performing teams, and Operational Excellence to set a global standard for high-volume, highly-efficient Drug Product manufacturing. The facility, planned for launch in 2028, will focus on CVRM (Cardiovascular, Renal, and Metabolism) medicines, specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high level of accountability, offering a unique opportunity to launch a new facility from the ground up and shape its culture.

This role seeks a highly skilled and experienced Quality Validation Engineer with a focus on Compounding, Filling, and Inspection. The position provides quality oversight for all validation and qualification activities related to the Holly Springs facility's equipment, systems, facilities, and utilities. During the plant start-up project, the engineer will represent QEV on the User Team and be accountable for the qualification of all Compounding, Filling, and Inspection systems. The role involves partnering and collaborating with various organizations including Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, and Strategy, providing expertise in project management, technical design, testing, qualification, validation, and other activities related to the design and start-up of a new Drug Product Fill and Finish facility.

Requirements

• For the senior principal level, 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, 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.
• Recognized expert / authority in qualification of Compounding, Filling, and Inspection systems in support of Drug Product manufacturing.
• 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.
• 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.
• Direct experience presenting to Regulatory Agencies and supporting technical experts with quality/compliance issues.
• 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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees