Principal/Senior Principal Quality Engineer, Validation - Utilities/Warehouse/HVAC (CVRM)
About The Position
This position is for a highly skilled and experienced Quality Validation Engineer at Roche/Genentech's new $2B greenfield start-up facility in Holly Springs, North Carolina. This state-of-the-art facility will leverage advanced automation, robotics, digital tools, and real-time data analytics for high-volume, highly-efficient Drug Product manufacturing, focusing on CVRM (Cardiovascular, Renal, and Metabolism) medicines, particularly for the global obesity epidemic and Type 2 diabetes. The plant is scheduled for launch in 2028. The successful candidate will provide Quality oversight for the qualification strategy and all validation and qualification activities of the facility’s equipment, systems, facilities, and utilities, with a specific focus on Utilities. During the plant start-up project, this role will be on the User Team representing QEV and will be accountable for the qualification of all Warehouse, HVAC, and Utilities systems. The engineer will partner and collaborate with various internal and external organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management, technical design, testing, qualification, validation, and other activities related to the design and start-up of the new Drug Product Fill and Finish facility. This is a fast-paced, entrepreneurial environment with a high level of accountability, offering a unique opportunity to shape the culture of the organization.
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 assembly and packaging equipment.
- 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.
- Experience in qualification of Utility Systems in support of Drug Product manufacturing including but not limited to WFI, clean steam, process gases, HVAC/R, waste neutralization, refrigerated water, and bulk chemicals.
- Experience in multiple disciplines of Qualification and Validation including two or more of the following: equipment qualification, cleaning validation, process validation, computer systems, shipping qualification, sanitization/sterilization.
- Ability to solve problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
- Experience supporting audits/inspections 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.
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 Utilities, HVAC and Warehouse equipment and automation systems during the facility start-up project.
- Work collaboratively in cross functional teams to solve technical and quality issues.
- Act as a champion to establish a science and risk based approach to Qualification and Validation.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
