Principal Validation Engineer, CVRM

Genentech•Cary, NC

1d•$95,000 - $176,000•Onsite

About The Position

The Principal Validation Engineer develops, implements, and maintains validation status for application equipment and manufacturing processes. The role estimates qualification and material needs, verifies prerequisite completion, works independently with minimal guidance, and provides functional guidance and support to less-experienced colleagues. The position supports technology transfer and new technology introduction at Genentech’s Holly Springs, North Carolina site. The engineer is accountable for equipment commissioning and qualification, cycle development, performance qualification, requalification, cleaning validation, and process validation. The site is building a highly automated drug product manufacturing facility intended to launch operations in 2028 and produce cardiovascular, renal, and metabolism medicines. The role also contributes to project execution, regulatory submissions, risk management, change management, audits, and Health Authority inspections. Relocation benefits are available. The expected salary range is $95,000–$176,000, with a discretionary annual bonus potentially available based on individual and Company performance.

Requirements

Bachelor’s or master’s degree in chemical engineering, biochemical engineering, or a related field/experience.
At least 8 years of experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services.
Experience in the pharmaceutical or biotechnology industry.
Knowledge of cGMPs or equivalent regulations.
Working knowledge of facilities, utilities, formulation, filling, and packaging, and equipment qualification in a regulated environment.
Hands-on qualification experience with the majority of sterile filling equipment and support systems.
Demonstrated project-management skills.
Ability to work with internal teams, partners, suppliers, and customers.
Professional-level written and oral communication skills.

Nice To Haves

Operational excellence skills.
Industrial engineering skills.

Responsibilities

Develop and manage detailed project plans, validation plans, and timelines for validation activities.
Author, execute, and summarize qualifications for sterilization systems and equipment, cleaning systems, filling equipment, and supporting equipment such as autoclaves and parts washers.
Prepare change-control documentation, including protocols and summary reports, for activities.
Support project managers in implementing new systems within established timelines and financial forecasts.
Present and explain completed work during periodic audits and Health Authority inspections.
Procure and manage contractors for outsourced validation and risk-management assignments.
Support change management for new processes, equipment, utilities, and facilities.
Prepare, review, and approve relevant sections of regulatory submissions.
Represent risk management on cross-functional and multisite teams, integrating it into Product Quality Systems such as Discrepancy Management, Change Control, and CAPA.
Lead and facilitate risk-assessment sessions.
Provide input to investigations and change controls that could affect the site risk profile.
Promote continuous learning and maintain expertise in technical and industry advancements.
Mentor junior validation engineers and train individuals on practices and procedures.
Collaborate closely with site and network organizations.
Seek creative and innovative solutions to maintain high productivity.
Provide leadership to help maintain a high-performance culture.