Principal/Senior Principal Quality Engineer, Validation - Assembly & Packaging (CVRM)

Roche•South San Francisco, CA

1d•Onsite

About The Position

This role is for a highly skilled and experienced Quality Validation Engineer with a focus on Assembly and Packaging at Roche/Genentech's new $2B greenfield start-up facility in Holly Springs, North Carolina. This state-of-the-art facility, launching in 2028, will be dedicated to high-volume, highly-efficient Drug Product manufacturing, leveraging advanced automation, robotics, digital tools, and real-time data analytics. The plant will produce CVRM (Cardiovascular, Renal, and Metabolism) medicines, specifically targeting the global obesity epidemic and Type 2 diabetes. The successful candidate will provide quality oversight for all validation and qualification activities of the facility’s equipment, systems, facilities, and utilities. During the plant start-up project, the engineer will represent the Quality Engineering Validation (QEV) User Team and be accountable for the qualification of all Assembly and Packaging equipment and supporting systems. The role involves partnering with various organizations like Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, and Strategy to provide expertise in project management, technical design, testing, qualification, and validation for the 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 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 assembly and packaging equipment.
Recognized expert / authority in qualification of automated production equipment in support of Drug Product manufacturing including but not limited to assembly and packaging systems.
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.
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.

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 Assembly and Packaging 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 Assembly and Packaging 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.